(http://bme.freebbs.tw 醫學工程論壇 同步發表)
ConMed Linvatec - Power Pro Handpieces
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181784.htm
ConMed Linvatec - Universal Cables
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181786.htm
Recall Class:Class I
Date RecallInitiated:July 31, 2009
Product:Universal Cables, MC5057-->我們醫院用的是MC5056，但因為財產沒有登記細項，必需去清查一下或是問一下台灣代理商
The lot numbers affected by this recall are included in this attachment. The cables have date codes etched on one end of the cable and range from JAN-01 to NOV-06 representing the month and the year.Attachment: Universal Cable Serial Numbers, Excel (158kb)These cables were manufactured from January 3, 2001 through November 30, 2006 and distributed from January 24, 2001 through February 27, 2009.See related Linvatec Class I recall
Use:The cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source.
Recalling Firm:Linvatec Corporation doing business as (dba) ConMed Linvatec11311 Concept BoulevardLargo, Florida 33773-4908
Reason for Recall:The cable may cause the electric handpiece to self-activate.
Public Contact:ConMed Linvatec Customer Service1-800-237-0169Monday-Friday, 7 AM to 7 PM Eastern TimeFor more information, see Useful Links below.
FDA District:Florida
FDA Comments:The company sent a letter to their customers with the following instructions:
Inspect the cords for signs of excessive wear or damage.
Stop using the cable if damaged or worn and replace it immediately.
Stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs. Return the cable and handpiece to the company for evaluation.
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 injury or death.Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.Useful Links:
Firm Press Release http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
2009年9月24日 星期四
LifePack電擊器(AED)一級回收(特定序號)
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm182458.htm
Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Recall Class: Class I
Date RecallInitiated: July 31, 2009
Product: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED)
Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers
37026963, 37026983, 37026984, 37026997, 3702700237027008, 37027039, 37027040, 37027049, 3702705337027063, 37027065, 37027066, 37027070, 3702707137027073, 37027075, 37027090, 37027099, 3702710537027122, 37027197, 37027529, 37027569, 3703139337037850, 37037893, 37037986, 37038002, 3703821137038365, 37135986, 37154526, 37154638
The serial number is located on the underside of the device.
The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.
Use: This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.
Recalling Firm: Physio-Control, Inc.11811 Willows Road NERedmond, Washington 98052-2003
Reason for Recall: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Public Contact: Physio-Control Customer Care1-800-442-1142, 6 AM through 4 PM Pacific Time
FDA District: Seattle
FDA Comments: Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
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 injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.
Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Recall Class: Class I
Date RecallInitiated: July 31, 2009
Product: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED)
Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers
37026963, 37026983, 37026984, 37026997, 3702700237027008, 37027039, 37027040, 37027049, 3702705337027063, 37027065, 37027066, 37027070, 3702707137027073, 37027075, 37027090, 37027099, 3702710537027122, 37027197, 37027529, 37027569, 3703139337037850, 37037893, 37037986, 37038002, 3703821137038365, 37135986, 37154526, 37154638
The serial number is located on the underside of the device.
The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.
Use: This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.
Recalling Firm: Physio-Control, Inc.11811 Willows Road NERedmond, Washington 98052-2003
Reason for Recall: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Public Contact: Physio-Control Customer Care1-800-442-1142, 6 AM through 4 PM Pacific Time
FDA District: Seattle
FDA Comments: Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
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 injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.
2009年9月17日 星期四
水銀洩漏地面收集
(http://bme.freebbs.tw 醫學工程論壇同步發表)
這不算是故障，而是插曲，算是工作上的插曲，也是我第一次碰到的。
通常水銀會洩漏都是因為水銀血壓計有問題，而漏在桌面上或是盒子裡，這樣對使用者或維修的人來說一張紙片就足以應付了，但今天的狀況是滿地開花！麻煩的是連地上瓷磚的小縫隙都有，真的很傷腦筋，這也凸顯出在醫院裡使用無縫地毯的需要性。
本來使用單位打電話下來只說水銀漏了，很自然的回答請她們用紙片鏟起來，用小瓶子裝好送下來集中。結果不一會兒，有人打電話下來很義正詞嚴的說，你們怎會讓護理人員蹲在地上用紙收集水銀呢?水銀很毒呢，那麼多人在那踩來踩去的，會讓人中毒的，你們應該有什麼設備可以來清除水銀吧！
清除水銀？我們又不是每天碰到這種事，怎會有這種設備呢，就婉言回答，水銀會毒是因為變成水銀蒸氣吸入人體才會造成問題，目前是元素型態時，是不會有太多問題的，我們會上去看看，不過我們也是只能用紙去鏟！
到了現場，真的是傻眼，怎會有人把水銀灑滿地呢，當下請人都出去護理站，因為開空調，本來是應該停空調開窗通風的，但天氣太熱，估計一會就可以清除，所以就沒開窗通風，蹲在地上，真的是沒法用紙鏟，有的躲在縫中，根本耐它無法，想想只能用吸的，可是一般吸塵器會把水銀打碎並且會經過排氣變成水銀蒸氣，那更慘哦，突然靈機一動，跟理站要了小型的motor suction，平常用來抽痰的吸引器。
-798325.jpg)
一般suction有緩衝瓶，不會直接吸入馬達，應該可以，借到了suction，用矽膠管壓著開始吸水銀了，真的很好用哦，而且吸進去的水銀因為緩衝瓶的作用，都收集在瓶中，再加上suction的空氣不會太熱，所以應該不會變成水銀蒸氣。連小縫裡都乾乾淨淨的，差不多連地板都吸乾淨囉，任務圓滿達成。
-702756.jpg)
所以提供大家參考，可以用suction來吸水銀，記得吸力不要開太大，緩衝瓶高度要夠，以免水銀又飛濺出去那就不好了，千萬不要拿吸塵器直接吸，那真的會讓水銀無影無踪的。如果前面再加個緩衝瓶，那才可以哦。
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