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

   原文下載

ECRI 2011~12 十大醫療技術危害比較(紅色為次列入在醫療技術危害)

 

	2011	2012
1.	Radiation Overdose and Other Dose Errors during Radiation Therapy 放射治療過程中，輻射劑量超標或錯誤	Alarm Hazards 各種不適當警報造成的問題
2.	Alarm Hazards 各種不適當警報造成的問題	Radiation Overdose and Other Dose Errors during Radiation Therapy 放射治療過程中，輻射劑量超標或錯誤
3.	Cross-Contamination from Flexible Endoscopes 軟式內視鏡使用時的交叉感染	Medication administration errors using infusion pumps
4.	The High Radiation Dose of CT Scans CT高輻射劑量造影	Cross-Contamination from Flexible Endoscopes 軟式內視鏡使用時的交叉感染
5.	Data Loss, System Incompatibilities, and Other Health IT Complications 資訊系統中的資料遺失或不相容問題	Inattention to change management for medical device connectivity
6.	Luer Misconnections Luer連結頭錯接，(造成給藥錯誤)	Enteral feeding misconnections
7.	Oversedation during Use of PCA Infusion Pumps PCA幫浦使用中造成Oversedation 問題	Surgical Fires 手術室火災
8.	Needle sticks and Other Sharps Injuries 針刺或尖銳物刺傷問題	Needlesticks and Other Sharps Injuries 針刺或尖銳物刺傷問題
9.	Surgical Fires 手術室火災	Anesthesia Hazards due to Inadequate Pre-Use Inspection 不當的使用前檢查所造成的麻醉機問題
10.	Defibrillator Failures in Emergency Resuscitation Attempts 急救時電擊器失效問題	Poor usability of home-use medical devices

一級召回 Mizuho OSI Modular Table Systems

(http://bme.freebbs.tw 醫學工程論壇同步發表)

原文(Original)

Mizuho OSI Modular Table Systems

國內有引進: 衛署醫器輸壹字第001537號 代理商是韶田公司

Recall Class: Class I

Date Recall Initiated: October 26, 2011

Product: OSI Modular Table Systems (including Modular Bases, Jackson Spinal, Imaging, Lateral, & Orthopedic Tops)



Manufacturing From: January 1992 - June 2011

Distribution From: January 1992 - June 2011

The affected models and lot numbers can be found below:

Model	Product Name
5803/5803I	Advanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz
5890	Retractable "I" Base - Manual tilt & lock functions
5891	Non-Retractable "I" Base - Manual tilt & lock functions
5892	Advanced Control Retractable "I" Base - electric powered tilt & lock
5855	Orthopedic Trauma Table Top
5895	Maximum Access Lateral Top
5927	Radiolucent Imaging Top with Tempur-Med
5840-726	Imaging Top w/ Tempur-med pad (part of Model 5827 System)
5840-831	Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System)
5943	Jackson Spinal Table
5843AP	Jackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz
5943API	Jackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz
5996/5996I	Advanced Control Pad System Variable Speed
6977	AXIS Jackson System with Advanced Control Pad System 100/230 VAC 50/60Hz

Use: For patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures.

Recalling Firm:
Mizuho Orthopedic Systems Inc
30031 Ahem Avenue
Union City, CA 94587

Reason for Recall: There are reports of injury related incidents while using Mizuho OSI Modular Table Systems. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death.

Public Contact: Questions should be directed to Mizuho on their toll-free hotline at 1-800-777-4674, Monday through Friday from 9:00 am to 5 pm, Pacific Time

FDA District: San Francisco

FDA Comments:

On July 29, 2011, Mizuho, in recognition of past failure modes, issued a Field Advisory Notice to Hospital Risk Management, Operating Room Directors, Operating Room Technicians, Physicians, Nurses, Anesthesiologists and any personnel involved in the use and/or set up of the OSI Modular Table Systems. The Field Advisory Notice provided warnings and recommendations for safe use of the Mizuho OSI Modular Table Systems including performing a verification count of all the T-pins to confirm the stability of the table top.

While FDA agrees that the factors identified by the firm may have contributed to some reported failures, FDA is concerned that the firm has not identified all factors contributing to these events.

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 Program¹ either online, by regular mail or by FAX.

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Siemens Medical grade LCD(DSB 1803-DC) 亮度不足

(http://bme.freebbs.tw 醫學工程論壇同步發表)

名稱: Siemens Medical grade LCD (DSB 1803-DC)
故障情形：亮度不足
故障原因：高壓板故障

這也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。

這次例子較特別，零件的取得是較特殊的，是心導管手術用的醫療級單色灰階 LCD螢幕，拿下來時是因為螢幕的亮度不足，跟正常的比較暗了許多，詢問Siemens原廠，只能正個更換，報價30~40萬..@@

規格：DSB 1803 DC, 1 MPIXEL, 18,1 GRAYSCALE LCD MONITOR W/O ，STAND RESOLUTION: 1280X1024 ，INPUT VOLTAGE: 90-264V (跟totoku有比哦)

這實在是有點換不下手，就要求同事，電路檢查一下是否一樣有電容問題，結果拆開後，只有一片影像板，是pixwork廠牌，這是核心之一吧。沒什麼太多的電容可以檢查，電源部份看到一些異樣(其實沒什麼問題，只是剛開始都會看到黑影就開槍...呵．．),也沒什麼大問題，原本以為是變壓器有問題，造成電壓不足，使變頻板輪出不足，跟另一台作交叉比對，證明．．想錯了．．．哈．．．

找半天找不到高壓板，看來還得繼續拆下去，鼓勵同事繼續拆下去，果不其然，高壓板就藏在裡面，拿出來看半天(J07I043.00 AMBIT REV:3)，哈．．．也是看不出所以然，只看到變壓器上都有些許烤焦的痕跡，不過在高壓板算是很常見的，再麻煩同事跟別台交叉比對，YA...果真是高壓板的問題，問題來了，沒一模一樣的東西，討論後，買個通用的六燈高壓板，看能不能點亮燈管，結果失敗．．看來還是得找一樣型號的電路板，機會大一點。

再度請出google，結果在對岸的拍賣網找到幾個一樣型號的電路板,一字不差(J07I043.00 AMBIT REV:3)，，心裡很猶豫，要不要設法買回來試看看，想到花費差距近百倍，就就同事多費神，直接訂了買了，時間花費近1週(其實想起來也很快)，裝上去，不錯．．．真的解決了．．不錯的經驗，也讓我們多了一個零件的來源。