輻防警示燈

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名稱: 輻防警示燈

故障情形：不亮

故障原因：不同電壓不同變壓器

輻防警示燈這在可發生游離輻射設備的房間前面一定要裝的東西，10多年來，根據法規的不同及檢查員的認知也有不同的要求，從早期的紅燈到現在的紅綠燈；

從早期的紅燈+電源連動到現在的電源連動綠燈，輻射連動紅燈，但這都不是重點，重點是設備端的多樣性才讓人頭痛。

一般設備上都會提供一組輸出電壓來驅動輻防警示燈，各家電壓都不同，有12VDC,24VDC,115VAC,220VAC...至少這是我碰到的電壓，所以這種警示燈有的就得根據要求有不同的規格。

以前都慣用消防用警示燈來改，但近來，消防都改用紅色的，所以綠色的貨源越來越少，我們家電工就很天才找了會旋轉的來代用，一轉起來，真的是Orz，沒幾天就燒了，所以就把馬達拆了，單會亮燈就好了。

現在另外有用電源儀板用的指示燈，好處是可以配合不同電壓有不同規格，其實說穿了，就是內藏一組變壓器，有時沒注意就燒了！想想燒了，乾脆就把變壓器拆了，燈泡直接接線;這樣只要根據不同電壓換不同燈泡就好了，省得還得再買一次，算是克難英雄啦。

Toshiba KXO/50R 控制面板不亮

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名稱: Toshiba KXO/50R
故障情形：控制面板不亮
故障原因：燈管Inverter機板問題

這台是Toshiba x光機的控制面板，說穿了也是一台單板電腦，配備10吋的LCD螢幕，以前因為沒有處理LCD螢幕的經驗，所以大部份有問題，都是直接換掉，庫存也有二個故障品。這次因為Toshiba有特別說，這型號都己停產了，所以只能用良品交換，他們是送回日本再修理，

  

因為有先借我們一台，所以有點時間可以處理看看，同事說，確定有影像，應該是點燈的電路板掛了，Toshiba也有試著換了保險絲，還是一樣，所以可能需要換整台了...@@．．．要價不斐哦

  

因為庫存有二個，我覺得有機會可以試試，就請Toshiba送回來，讓我們試試，拆到以前的板子，也是一樣保險絲都燒了，補上一個，直接點燈看看，Bingo，再把另一個也處理一下，呵．．．不錯，也都OK了。

 

把救回來的Inverter裝回原來的控制面板，OK,只是現在都標謗環保材質，黑色後蓋都有點酥掉了，真的是環保與耐用不可兼顧。

SHIMADZU MUX100 開機時 D9 Error

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名稱: SHIMADZU MUX100

故障情形：開機時 D9 Error

故障原因：防撞感知微動開關故障

過年放假前一天，才推下來這傢伙，SHIMADZU的防撞感知器，在碰到東西時會嗶嗶聲，電源燈會閃爍，沒有任何紅色警示燈，但這次是開機時會出現紅色ALARM及D9 Error code，同時也不走了，只能後退，根據這點，同事們確認應該是防撞感知器有問題，明天又開始要放假，還是自己得先動手更換了，又是大傢伙，真感謝及辛苦這些同事了。

拆下防撞感知器機構，真的是微動開關破了，還好之前有買類似的零件，150元搞定!

 年假前，真感謝及辛苦這些同事，也讓使用單位能順利執行業務了。

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我己經在台灣FDA的網站上留言.及寄給相當的業務部門,看有沒有具體的回應或說明,也許公家部門有公家部門的考量,

如果大家有不同的想法或意見,也歡迎表達一下。
-----------------

1. 國內藥事法中規範把藥品跟醫療器材合在一起管理，但藥品跟醫療器材本質上就不同，所以在管理及查核上除了對人體影響是共同點外，幾乎是完全不同。
藥品著重在生物化學層面上的變化，醫材是在生理物理上面的應用及處理，
藥品不會有所謂的調整及保養需求，醫材則不會有所謂的藥物過敏現像，
在現今的應用及管理上己經有點無法應付，建議應該修法分開各別訂定管理辦法。

2.  貴署ADR通報上的公告實屬不錯，但以醫院醫學工程從業的角度及一般民眾的查詢需求上，建議可以改善幾點，以使公告內容更完善：
Recall  --不同於一般藥品的回收，而是可以利用額外手段加以修正處理，所以建議改為 召修較貼切，避免讓民眾誤解。
公告欄分類部份--全部都是”來函轉知”，在查詢上沒什麼助益；建議可以分為”安全通報(Safety Communication)”及”召修(Recall)”，再配合查詢年月，可以更方便民眾詢

3.QSD登記查詢中，建議增列醫器規格，因為廠商在送審的名稱跟販賣時的商名會有極大的不同，(如送審登記名稱是”XXX眼底照相機”，外面的商名是”全功能螢光眼底照相機暨數位影像系統”…，如果不是醫工人員，誰會知道是眼底照相機，一定是去查“螢光“作關鍵字…Orz)。

但大部份的人都會知道醫療器材的廠牌及型號，所以建議在QSD登記中，把醫器中的規格列為可查詢的欄位方便查詢，(最好是跟藥品分開各別查詢，一如中藥材查詢，因為本質就不同了)

也不致於讓廠商魚目混珠，用一個籠統的名稱就含括所有的型號，這是目前我們醫工人員在驗收時的困擾，如果可以增加醫器規格查詢欄位，勢必可以減少從業人員及民眾查詢的困擾。

4.  QSD登記查詢中，的註銷欄位是否可以預設為“未註銷“，往往會忘了選擇，查到時多了很多都是己註銷的，得重新查詢不然就得逐一翻頁，浪費網路頻寬又浪費查詢時間，建議可以改善。

一級召修 Covidien, Puritan Bennett 840 Series Ventilator - Software Problem

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Covidien, Puritan Bennett 840 Series Ventilator - Software Problem

＊＊＊ 衛署醫器輸字第010179號 ＊＊＊

 

Recall Class: Class I

Date Recall Initiated: December 16, 2013

Product(s): Puritan Bennett 840 Series Ventilator

Model/catalog/lot numbers: Software Part Number 4-070212-85, Revision AB-AG

Range of manufacturing and distribution dates: 
Manufactured: April 30, 1998 to March 12, 2010
Distributed: August 1, 2008 to October 31, 2010

Use: A critical care ventilator that provides continuous ventilation for infant, pediatric, and adult patients.

Recalling Firm: Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301-3214

Reason for Recall: Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death.

Public Contact: Customers with questions regarding this recall can contact Covidien Technical Services at 800-255-6774, Monday through Friday, from 6 AM to 5 PM Pacific Time (Menu option # 4). Customer service (Menu option # 3) is available Monday through Friday from 8 AM to 6:30 PM Eastern Time.

FDA District: Denver District

FDA Comments: On December 16, 2013, Covidien sent its customers an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue using their Puritan Bennett 840 ventilators until they are able to install the software update outlined in the letter.

There are several ways to install the software update. To initiate the process for updating the software and select the method for an individual facility, customers should go to the software update management portal atwww.PB840technicalupdate.com and follow the instructions to register.

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 Program either online, by regular mail or by FAX.

Additional Links:

• Firm Recall Webpage

水銀血壓計回收貯放

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名稱: 水銀血壓計回收貯放

故障情形：報廢拆解

故障原因：報廢

近幾年，環保署一直在追醫療用水銀的用量及廢棄物處理，醫院中的溫度計及血壓計是焦點之一。

目前可以取代水銀溫度計有很多，像電子溫度計、酒精溫度計...等，所以完全取代，應該是沒什麼爭議。

但是水銀血壓計就有很大的爭議了，因為血壓的量測單位是mmHg，所以水銀血壓計是直接物理量，根本不需要換算或是再處理(在不考慮水銀量足夠與否的情形下)，就可以直接顯示血壓值，所以在醫療上的參考價值是排第一位，心血管的臨床醫師也是較相信水銀血壓計的數值。

電子血壓計就有換算的電路，所以就會產生校正的需求，但是這幾年的發展下，精準度也是慢慢被臨床醫師接受，只有在懷疑數值時，再回頭用水銀血計再量一次。

其實，水銀血壓計只要水銀量足夠，基本上是不需要校正的，因為是直接物理量顯示，我們在護理站還是會保一些水銀血壓計，作為臨床重複確認用，維修校正也是會會水銀血壓計作並接確認數值。

但在環保的大旗下，還是逐漸在減量了，退下來的，當然不能隨便丟，統一拆解，零件歸類，作為維修使用，廢棄的水銀則是用容器裝好，再用膠帶封好，以免滲出。

拆解水銀血壓計時，最麻煩的是那些細細小小的水銀珠(特別是在拆玻璃管跟水銀槽時)，所以記得要用個大一點的容器承接，這樣那些小小的水銀珠才不會四處亂跑。

安全通報 Philips AED HeartStart FRx, HS1 Home, HS1 OnSite

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Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)

＊＊＊ 衛署醫器輸字第022831號 ＊＊＊   (登記為M5066A但商名為HS1)     the Philips HeartStart OnSite HS1

the Philips HeartStart FRx  未見QSD上有登記

HeartStart Home Defibrillator 未見QSD上有登記

Date Issued: Dec. 03, 2013
Audience:

• First responders who use Philips HeartStart FRx AED
• Consumers who have purchased Philips HeartStart HS1 Home or HeartStart HS1 OnSite AEDs

Medical Specialty: Cardiology, Electrophysiology, Internal Medicine, Family Medicine

Device:An automated external defibrillator (AED) is a device that analyzes the heart rhythm in victims of sudden cardiac arrest, and delivers an electrical shock to restore normal rhythm.
The Philips HeartStart FRx AED may be used by first responders including Emergency Medical Services (EMS) and fire departments.
The Philips HeartStart HS1 Home AED may be used in the home.
The Philips HeartStart HS1 OnSite AED may be used in public locations including airports, community centers, schools and government buildings.

Purpose: The FDA is alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.

Summary of Problem and Scope:In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. This recall affects approximately 700,000 devices.

In a Medical Device Safety Notice dated Nov. 19, 2013, Philips provided customers with updated information about the failure of an electrical component that could cause the AEDs to fail to deliver appropriate shock. The notification also directed consumers to a Maintenance Advisory¹ .

Recommendations:Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing "i-button" if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock. 

該設備會定時自我檢測，如果設備有出現三聲喳喳喳(chirp)(我沒碰過，所以沒法形容,^_^),同時I-button也在閃爍時,表示設備己測到嚴重故障，請即與Philps連絡檢修。

If your Philips HeartStart AED has ever emitted or begins to emit a pattern of triple chirps, please contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time.

• Keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator. 

If your Philips HeartStart AED is emitting a series of triple chirps during an emergency situation, and you are unable to locate another working AED:如果您的AED己有上述情形，又沒有替代品時

1. Call Emergency Medical Services (EMS) or 911 and start cardiopulmonary resuscitation  (CPR) (先打119,持續作CPR)

2. Press the flashing "i-button" and follow the voice prompts.  (按下I-button鍵，並依語音操作)

3. If there is an error message, remove and reinsert the battery to attempt to clear some errors and equip the device to deliver an electrical shock if needed. (Note: This step should be followed ONLY during an emergency situation.) (若螢幕上有顯示錯誤訊息，請把電池拆下並重裝，再試看看是否可正常使用，如果己經在急救時，可以試電擊，看有沒有電擊能量輸出。)

4. If an advised electrical shock is not delivered, continue CPR while you wait for EMS. （如果仍無法電擊，持續作CPR待急救人員到達接手）

5. After the emergency is resolved, contact Philips Healthcare for a replacement unit. (事後請連絡Philips檢修設備)

FDA Actions The FDA continues to closely monitor all AED manufacturers' quality system design practices and device malfunctions that have persistently contributed to AED recall and Medical Device Reports.

In September 2012, the FDA classified Philips' recall of HeartStart AED devices as a Class II recall after determining that the chance of serious adverse consequences or death due the device failure is remote. In this current situation, the FDA believes that because the patients who need these devices are in a life threatening situation, the chance of serious adverse consequences or death directly related to AED failure is very difficult to conclusively determine.

In March 2013, the FDA issued a Proposed Order² requiring manufacturers of AEDS and accessories to submit premarket approval (PMA) applications. The FDA is currently reviewing and considering the comments provided by the public, and will take them into consideration when issuing a final order.

Reporting Problems to the FDAPrompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that an AED has malfunctioned, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program³.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements⁴ should follow the reporting procedures established by their facilities.

Contact Information:If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at industry.devices@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Additional Resources:

• FDA press release⁵
• Philips Maintenance Advisory: HeartStart FRx and Onsite (HS1) AEDs ^{6 7}