Philips 超音波 Envisor (M2540) 影像變色

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名稱:Philips 超音波 Envisor (M2540)
故障情形：影像變色
故障原因：影像卡ATI Radeon 7000 (32MB)故障。

Philips Envisor的設計是以二台PC為影像處理核心，基本上除了前級的板子是Philips專用的以外，這二台PC原則上是跟一般PC一樣的，只是因為應用在醫療上，所以軟體上會鎖硬體，還會提醒如果更換硬體後要以原廠的SERVICE KEY去安裝DRIVER。

這台Envisor在去年就有過因為無影像輸出拖回來處理，結果確認是影像卡(Video Card)ATI Radeon 7000 (32MB)掛了，剛開始以為換片影像卡就oK了，結果到了進系統時就被擋了。

沒辦法只好找一模一樣的卡回來換，PC的更替是很快的，這片ATI Radeon 7000 (32MB)己經算是古董級了，找Philips問，沒第二句話，換整台pc，大概要15~20萬吧，真的換不下手了。

還好網拍上有同型的二手卡在賣，買了一片回來，換上去，反正死馬當活馬醫，Bingo，可以了，解決了這個問題。

一轉眼也過了一年，最近又有點變色，依據去年的經驗，應該還是影像卡有問題，問題是沒有一樣的只有另一片是64MB的，試看看吧，結果也可以，看來重點是在晶片組，只要是ATI Radeon 的晶片組都可以。

為了預防萬一，另外到網路上去買了幾片回來備用(二手的還便宜，只要幾百元)，可以擋著用。

還有要記得，因為Envisor偵測到硬體更換後，會自動偵測螢調整解析度，如果更換卡後，最好直接回到機器上去開機，因為機器本身的螢幕是15吋的，不要把PC抱回辦公室用17吋的開機，會造成回機器後，解析度不合無法顯示的問題，這是我們慘痛的經驗多花了近2個小時才想通，搞定。

如果你們家也有Envisor的機器，影像有問題時，記得可以換看看這片卡哦。

一級回收CareFusion Corporation, Alaris PC Units (Model 8015)

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根據衛生署的QSD登記中，並無8015PC系統的登記，國內應該沒有。只有德業聚公司代理的carefusion呼吸器

CareFusion Corporation, Alaris PC Units (Model 8015)

Recall Class: Class I

Date Recall Initiated: July 13, 2010

Product: Alaris PC unit (model 8015)

The Alaris PC Unit Model 8000 is NOT affected by this recall.

The affected serial numbers are found on the company's website. See below under Useful Links.

These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.

Use: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

Recalling Firm:
CareFusion Corporation
10020 Pacific Mesa Boulevard
San Diego, California 92121

Reason for Recall:
Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.

If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death.

Public Contact:
Customers may contact the company at their CareFusion Recall Support Center, Monday through Friday, 7 AM through 4 PM Pacific Time, at 1-888-562-6018 or by email at SupportCenter@carefusion.com

FDA District: Los Angeles

FDA Comments:

On August 24, 2010, CareFusion sent their customers using the affected Alaris PC Units a recall notification letter with a Response Card by registered mail. Customers were required to confirm receipt of the notice by returning the Recall Response Card, by FAX or mail.

The recall notice informed the customers of the reason for the recall, the units affected, the potential risk, a step-by-step description of the issue, and the required actions for users. CareFusion will contact the affected facilities by phone or in person within 60 days of receipt of the recall notice to initiate corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.

Until corrective action is taken, if users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links:

• Firm News Release
• Firm Recall Notice, FAQs, Error Tip Sheet, and Affected Serial Numbers
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Symbiq One and Two-Channel Infusers 一級回收

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Symbiq One and Two-Channel Infusers 一級回收

 

Recall Class: Class I

Date Recall Initiated: March 26, 2010

Product: Symbiq Infusion System

Brand Name:
Symbiq One-Channel Infuser
Symbiq Two-Channel Infuser

Model Numbers:
16026 Symbiq One-Channel Infuser
16027 Symbiq Two-Channel Infuser

Dates of Distribution: December 23, 2006 – January 22, 2010

All lots are affected and can be found in the following List Number Configurations:

Model Number-Country/ Language Code-Inventory Code	Model Number-Country/ Language Code-Inventory Code
16026-04-01/03/04 16026-04-51/52 16026-04-53/54 16026-04-79/80 16026-04-81/82 16026-04-83/84 16026-04-87/88 16026-04-89/90 16026-13-25/26 16026-13-53/54 16026-27-89/90	16027-04-01/03/04 16027-04-51/52 16027-04-53/54 16027-04-79/80 16027-04-81/82 16027-04-83/84 16027-04-87/88 16027-04-89/90 16027-13-25/26 16027-13-53/54 16027-27-89/90

Use: The Symbiq One and Two-Channel Infusers are infusion pumps intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

The systems are available as a one-channel or a two-channel infuser and may be connected to configure a three or four channel pump. The cassette-based system is powered by either AC power or can be powered by a rechargeable battery. The Symbiq Infusion Systems deliver basic therapy or advanced therapies such as multi-step, intermittent, and inter-channel sequencing.

Recalling Firm:
Hospira Inc.
775 Jarvis Drive
Morgan Hill, California 95037

Reason for Recall: There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the "Check Flow Stop" alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide appropriate warning to users. Unrestricted flow of medication an/or other therapy has the potential to cause life-threatening effects and/or critical patient injury, especially in specific patient groups such as critically ill patients, patients with congestive heart failure and/or neonates. The design of this device is being evaluated. The actions required under this recall will be supplemented with a long term solution to the "Check Flow Stop" alarm malfunction on a later date.

Hospira is reinforcing that it is imperative that clinicians using the Symbiq devices adhere to the operating instructions for removing the cassette from the infuser in order to mitigate free flow until a final correction is implemented. According to the firm, proper procedure for cassette removal is as follows:

1. Confirm the infusion pump is in "Stop" mode, and close the administration set roller clamp, and/or slide clamp, prior to removing the cassette from the infuser.
2. Press the "Load/Eject" button to open the cassette carriage. Ensure the cassette carriage is fully opened. Do not remove the administration set until movement of the cassette carriage has stopped.
3. Grasp the tubing above and below the cassette. Slide the cassette upward and out of the cassette carriage.
4. The cassette carriage will close automatically in approximately 10 seconds. Alternatively, press the "Load/Eject" button to close the cassette carriage sooner.
5. To discontinue use of the device, press and hold the "On/Off" button for one second to power down.
6. Discard the administration set and fluid container per Centers for Disease Control, hospital, or healthcare provider guidelines.

Public Contact: Questions should be directed to Hospira, Inc. at 1-800-241-4002 Monday through Friday from 8:00 a.m. to 6 p.m. Central Time.

FDA District: San Francisco

FDA Comments:

Hospira mailed clinical bulletins to affected customers on March 26, 2010 directing them to remove the administration set (cassette) only after the roller/slide clamp has been closed and the cassette carriage is fully open. Hospira sent additional information to customers through an Urgent Product Recall letter on September 13, 2010. Distribution of this product has stopped pending corrective actions.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Useful Links:

• Hospira Symbiq Unrestricted Flow Recall (September 13, 2010)
• Hospira Symbiq Clinical Bulletin and Recall Notice (March 2010)
• FDA Infusion Pump Initiative Webpage

    

一級回收 Hospira Symbiq One-Channel and Two-Channel Infusers

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一級回收 INOMAX DS Drug-Delivery System
[Posted 09/10/2010]

點滴完成後空氣偵測可能失效，可能會使空氣逸入病人體內，己經個別通知處理方法，並不需停止使用。

AUDIENCE: Risk ManagerISSUE: Potential for the device to fail to detect air in line at the end of an infusion. Failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death.

BACKGROUND: The Symbiq Infusion System is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

RECOMMENDATION: Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira states the user does not have to remove or stop using the Symbiq infusion pump, and provided recommended mitigation actions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/31/2010 - Recall Notice - FDA]

一級回收 INOMAX DS Drug-Delivery System

(http://bme.freebbs.tw 醫學工程論壇同步發表)

查過了,國內並沒登記,應該沒有引進國內吧

INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow

[Posted 08/23/2010]

AUDIENCE: Pulmonology, Risk Manager

ISSUE: Ikaria, Inc. notified healthcare professionals of a Class I Recall of the INOMAX (nitric oxide) Drug-Delivery System. There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. An interruption or delay in the administration of INOMAX therapy may cause:

• Worsening of low blood oxygen level (hypoxemia)
• Low blood pressure (hypotension) and/or
• Increase in blood pressure in the pulmonary arteries (pulmonary hypertension)
• Death

BACKGROUND: INOMAX is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (> 34 weeks gestation) neonates with hypoxic respiratory failure.

RECOMMENDATION: If a leak is suspected, clinicians should: 1) not interrupt the delivery of INOMAX; 2) verify an adequate amount of INOMAX remains in the cylinder; 3) switch to the manual back-up system using the INOblender by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation, and; 4) contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) for assistance. Although the risk of INOMAX exposure to pregnant women is unknown, it is advised that healthcare professionals who may be pregnant avoid the immediate area in which a leak is suspected.

[08/23/2010 - Recall Notice - FDA]
[08/11/2010 - Press Release - Ikaria, Inc]

保養系統規劃流程圖

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醫工的工作中，定期保養是最重要的一環，也是評鑑時的重點，目前的保養，大概都是以醫療儀器為母體，再依特性作為保養安排。
有時因為受限於人力或物力，常會有漏勾的情形，我們也不例外，常會有漏的情形，目前在重新規劃保養自動排程的系統，概念其實很簡單，不過資訊系統不知道能不能寫得出來，因為我們家的MIS全部連採購、資材、財產等都連在一起，不是單純的維修系統，所以，規劃是出來了，再來就是與工務及其他維修單位討論是否均合適，，連欄位都規劃出來了，再交給資訊去coding了。

以下是我們規劃的流程草圖，提供大家參考，討論看看

一級回收：LIFEPAK 20 and LIFEPAK 20e

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一級回收：LIFEPAK 20 and LIFEPAK 20e

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

LIFEPAK 20 國內是由臺灣美敦力鼎眾股份有限公司代理，名稱為"美敦力理療控制" 來沛去顫器" (衛署醫器輸字第010364號)有使用的夥伴，請向該公司詢問看看。

Audience: Emergency Medicine, Cardiology, Risk Manager　[Posted 07/02/2010]

ISSUE: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.

RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.

[07/02/2010 - Recall Notice - FDA]