2013年8月20日 星期二

HP M1723B No Power

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名稱: HP M1723B 電擊器

故障情形:No Power,另一片 無法以電池電源操作
故障原因:頻率振盪用電容老化
本來這台 HP M1723B是同事在保養時發現AC電源正常,但切換到電池操作時,就斷電了;初步查修了一下,電池正常,應該是電路板有問題了。
因為是古早的機器了,零件也斷料了,同事就先找了廠商的良品來代換,原本以為不知道是多少片板子有問題,還好只是電源電路板更換後就OK了,就把電源板帶回來讓我試看看。
這片電路板是ZYTech OEM的型號是(zytech EP071178),整合了Power及DC-DC Inverter。因為沒線路圖,只能用一般的Switching Power的概念下去查修,因為AC正常,所以一直在查找是電池回輸時,那個環節有問題。終於查到一個電容漏液,不過神奇的是容值還有,從廢料堆裡找到一片也是同型的去年換下來的,先拆下代換一下這個電容,因為沒拿回去測試,也不知道是否OK,不過覺得應該還沒找到問題點,就先放著了。
看到原本在廢料堆裡的另一片電源板,突然想到,如果沒DC輸出,那是不是會較好查修,用一般的Switching Power的概念下去查修,呵,掛上示波器,真的初級振盪電路就沒工作了,再量一下UC2842的VCC輸入,原本的18V只剩12V,應該是這問題吧,往回查看18V在哪衰掉了,結果查到C11電容怪怪的,解下來,只剩15u,換了一個後,UC2842電壓回升到15V,示波器掛上,有振盪訊號了,Ya..再量一下,DC 14.1V,應該是OK了,請同事拿去裝上試看看,OK。


至於另一片無法以電池電源操作...那就慢慢查吧,至少有一片可以用了。

2013年8月13日 星期二

一級召修 Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit


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"優耐美"輸液系統 百世生醫科技有限公司  *** 衛署醫器輸字第018450號 *** (國內僅引進3850,QSD上未見3860登記)

"優耐美"輸液系統及其配件 輸液系統 百世生醫科技有限公司  *** 衛署醫器輸字第020272號 ***  (國內僅引進1055, 1056, 1057, 1119,QSD上未見1145登記)


Recall Class: Class I

Date Recall Initiated: July 1, 2013
Product: MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit. (3860配備1145DERS系統)
The MRidium 1145 Dose Reduction System (DERS) drug library kit is an accessory intended for use with the MRidium 3860+ Infusion Pump System.

This recall does not affect the following products: (未配備1145DERS都不受影響)

  • MRidium™ 3860+ Infusion Pump used without the DERS (Part No. 1145) Kit
  • MRidium™ 3861 Infusion Pump Channel B accessory.
  • MRidium™ 3865 Infusion Pump Remote Display accessory.
  • None of the MRidium™ 3850 Infusion Pump products (models 3850, 3851, or 3855).
Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.
These products were manufactured from Oct. 1, 2011 through June 27, 2013 and distributed from Oct. 6, 2011 through June 28, 2013.

Use: The MRidium 3860+ Infusion pumps are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with fluids and/or medications into the vein (intravenous) or through the artery (intra-arterial) before, during or after Magnetic Resonance Imagining (MRI) scans.

Recalling Firm:
Iradimed Corporation
7457 Aloma Ave., Suite 201
Winter Park, Florida 32792-9172

Reason for Recall: The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This is due to a specific key sequence when the override feature of the DERS drug limits is activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. This can cause serious adverse health consequences, including death.


Public Contact: Iradimed Customer Service (toll-free) at 1-866-677-8022 or 407-677-8022 ext. 100 or by e-mail at recallsupport@iradimed.com.
FDA District: Florida District Office


FDA Comments:
Iradimed Corporation notified its customers by phone and on July 1, 2013 they sent an URGENT MEDICAL DEVICE RECALL NOTICE1 disclaimer icon2 to all customers. The notice described the product, problem and actions to be taken.


The customers were instructed to identify the MRidium 3860+ Infusion Pumps which have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time. However, if the DERS Library card is installed, remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided in the URGENT MEDICAL DEVICE RECALL NOTICE.

The product will be repaired (reconditioned) by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle.


Users who have any questions following these instructions should contact Iradimed Customer Service toll-free at 1-866-677-8022 or 407-677-8022 ext. 100 or by e-mail at recallsupport@iradimed.com.

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 Program3 either online, by regular mail or by FAX.