一級召修 具CAS I/II Absorbers 的的Spacelabs麻醉機系統

(http://bme.freebbs.tw 醫學工程論壇同步發表)

"Spacelabs"BleaseFocus Anesthesia System "斯貝司"百利焦點麻醉機系統   衛署醫器輸字第023291號  漢佑股份有限公司

"Spacelabs" BleaseSirius Anesthesia System　"斯貝司"天狼星麻醉系統 衛署醫器輸字第023172號  漢佑股份有限公司

[03/26/2013] 才發佈過一次

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail

AUDIENCE: Risk Manager, Anesthesiology
ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. (The Bag to-Vent switch因固定鬆脫問題，可能會造成switch失效)

In the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally.
The affected products may cause serious adverse health consequences, including death.

BACKGROUND: These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

RECOMMENDATION: On Nov. 1, 2013, Spacelabs Healthcare sent an Urgent Medical Device Correction letter to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record by e-mail on Nov. 6, 2013.

(SaceLab己經發出通知信給各受影響的使用者，說明如何應因應，有使用本款設備的人，若沒收到通知信，請連絡代理商處理)
Customers were instructed to immediately advise their staff of the problem.

Customers with questions were instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
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

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376772.htm

Stryker infinite 用 LCD 電容故障

(http://bme.freebbs.tw 醫學工程論壇同步發表)

名稱: Stryker infinite 用 LCD

故障情形：No function.電源燈一直閃

故障原因：電容故障

這是最近幾次處理螢幕後，收割的結果之一；現在辦公室的同事只要碰到LCD螢幕有故障，都會先拿下來，檢查一下電容或更換掉後．大概有70~80%的機會完修。Philips 超音波的LCD螢幕也是，至少撙節了20萬吧(好像報價是這樣，不是很確定，處理好的滿足感較重要。)

這次例子較特別，是微創手術主機用的LCD(液晶螢幕)，本來以為是infinite主機有問題，重新開機好幾次，有時就OK，到最後終於罷工了，所以再拿了一台LCD先擋著用，結果17吋的也不行，再拿一台19吋的　可以了，那就先擋著用，觸控功能先改用滑鼠囉。可是拿下來接一般電腦又Ok，原本以為是析度問題，得找時間上去調整一下。

過了不久，又一台同樣的狀況，這次也是先借一台上去擋著用，再把故障的拿來接一般電腦，真的不行，所以真的是LCD掛了。

一檢查，電源板電容有二個有微凸(1200uf/10V)，先換下來再說，試看看，嗯OK，後來想到，之前這台該不會也是一樣吧，再拆開，還真的一樣電容問題，一併解決掉，還給使用單位觸控功能了，耳根子可以清靜一下了。

一級召修 Hospira Inc., GemStar Infusion System

(http://bme.freebbs.tw 醫學工程論壇同步發表)

Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift

＊＊＊ 衛署醫器輸字第009822號 ＊＊＊ 赫士睿" 寶星輸液暨疼痛處理幫浦

(國內引進的型號13000,13150。13086, 13087, 13088)

----今年5月才發布過鋰電池的Recall

Recall Class:  Class I
Date Recall Initiated:  March 15, 2013
Product:  Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088
All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.(影響設備自2009.01.01以後製造或更換過壓力sensor的pump)

The pump's date of manufacture can be found on the Product Identity label located on the back of the pump.
Use: The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.  The device can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries.  When powered by batteries, the GemStar Pump is used for ambulatory patients.
Recalling Firm:
Hospira Inc. 275 North Field Drive Lake Forest, Illinois  60045-2579
Reason for Recall:  The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test(近遠端壓力sensor在作阻塞測試時會出現失敗時，可能就是校正值漂移), as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:

• Cassette Check – D
• Cassette Check - P
• Proximal Occlusion  
• Distal Occlusion
• Pressure Calibration Error
• Bad Pressure Sensor Event
• Bad Pressure Sensor State
• Distal Pressure is Out of Range
• Proximal Sensor is Out of Range

(若有出現以上的Error Code,就有可能是壓力sensor校正值漂移)

A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.  This issue may also result in the pump shutting down.
Potential Risks:

• If these errors are observed, the infusion is stopped, resulting in delay/interruption in therapy.
• A full or partial occlusion may prevent fluid from reaching the patient, resulting in delay/interruption of therapy.
• An undetected distal occlusion may cause excessive pressure and fluid build-up within the distal line undetected by the pressure sensor. When the distal occlusion is resolved, the build-up fluid will be administered into the patient possibly causing a maximal over-infusion of <1.0 mL.
• The severity in the delay/interruption in therapy is dependent upon the underlying condition of the patient and the treatment being prescribed.  A delay/interruption in therapy has a worst case potential to result in significant injury or death.
• Depending on the drug and the dosage delivered, over-infusion has the worst-case potential to result in significant injury or death.

Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies.  Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in therapy or an over-infusion could result in significant injury or death.
Public Contact: Call Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 if you are unsure if the pressure sensor in your device has been replaced since January 1, 2009.
FDA District:  Chicago District Office
FDA Comments:

On March 15, 2013 Hospira sent its customers of record who purchased the device directly from them an "Urgent Device Field Correction¹" letter.  

Required Actions:

• Immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM Central Standard Time) to report the issue and arrange for the return of the device for recalibration.
• Add the performance of a proximal and distal occlusion test to your yearly GemStar maintenance schedule.
• Complete and return the attached reply form and return it to the fax number or email address on the form, even if you do not currently have the impacted devices. Contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to obtain additional copies of the reply form.
• Notify your accounts who may have received these devices from you if you have further distributed them and ask that they contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to receive a reply form.

（可以要求代理商 請先依原廠維修手冊，進行近遠端壓力sensor阻塞測試，並列入年度保養維護項目，並將檢測結果回傳Hospira公司)

Hospira Actions:

• Hospira is modifying the GemStar Technical Service Manual to add proximal and distal occlusion tests annually to confirm that devices do not require recalibration.

For further inquiries, contact Hospira using the information provided below.

Hospira Contact	Contact Information	Areas of Support
Hospira Global Complaint Management	1-800-441-4100 (8AM-5PM CST, M-F) (ProductComplaintsPP@hospira.com)	To report adverse events or product complaints
Hospira Advanced Knowledge Center	1-800-241-4002, option 4 (Available 24 hours a day/7 days a week)	Additional information or technical assistance

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program² either online, by regular mail or by FAX.

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2012~2014 (ECRI 2014 十大醫療技術危害 )

(http://bme.freebbs.tw 醫學工程論壇同步發表)

Top_10_Hazards_Executive_Brief.原文網址

Alarm hazards、Pump,輻射、內視鏡問題及IT相關問題  己經連續三年蟬聯囉

手術機器人的問題第一次出現，看來醫生對使用Robot要有重新的認知跟訓練，
可能較少打電動玩具吧  ^^

	2014	2013	2012
1	Alarm hazards   各種不適當警報造成的危害	Alarm hazards  各種不適當警報造成的危害	Alarm hazards 各種不適當警報造成的危害
2	Infusion pump medication errors 點滴幫浦的給藥錯誤	Medication administration errors using infusion pumps 點滴幫浦給藥量錯誤	Exposure hazards from radiation therapy and CT 放射治療及電腦斷層輻射曝露危害
3	CT radiation exposures in pediatric patients 在兒科患者的CT輻射暴露	Unnecessary radiation exposures and radiation burns during diagnostic radiology procedures 非必要輻射曝露及檢查過程中輻射灼傷	Medication administration errors using infusion pumps 點滴幫浦給藥量錯誤
4	Data integrity failures in EHRs and other health IT systems 電子健康檔案和其他醫療IT系統的資料整合失敗	Patient/data mismatches in EHRs and other health IT HIT systems 電子病歷及其他健康資訊資料錯誤	Cross-contamination from flexible endoscopes 軟式內視鏡的交叉污染
5	Occupational radiation hazards in hybrid ORs 混合式手術室的職業輻射危害	Interoperability failures with medical devices and health  IT systems 醫儀與資訊系統連線管理疏忽	Inattention to change management for medical device connectivity 醫儀與資訊系統連線管理疏忽
6	Inadequate reprocessing of endoscopic devices and surgical instruments 內視鏡設備和手術器械再處理的不足	Air embolism hazards 空氣栓塞危害	Enteral feeding misconnections 餵食管的錯誤連接
7	Neglecting change management for networked devices and systems 忽略聯網設備和系統的變更管理	Inattention to the needs of pediatric patients when using "adult" techniques 用成人治療技術未注意小兒病患的差別需求	Surgical fires 手術室火災
8	Risks to pediatric patients from "adult" technologies 使用"成人"技術時導致的兒科患者的風險	Inadequate reprocessing of endoscopic devices and surgical instruments 軟式內視鏡及手術器械的交叉污染	Needlesticks and other sharps injuries 針頭或其他銳器傷害
9	Robotic surgery complications due to insufficient training 由於訓練不足所導致的機器人手術併發症	Caregiver distractions from smartphones and  other mobile devices 智慧型手機或行動裝置造成醫護人員分心	Anesthesia hazards due to incomplete pre-use inspection 檢查疏失造成的麻醉意外
10	Retained Devices and Un-retrieved Fragments 遺留的物件和無法恢復的碎片	Surgical Fires 手術室火災	Poor usability of home-use medical devices 家用醫療器材可用性不佳造成的意外