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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HEATER COOLER UNIT
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The field service technician (fst) was onsite. The fst replaced the power control board and the vacuum valves, cleaned clorina residue from around the of the machine. After power up machine and run diagnosis checks -all check passed ok. The most probable root case is a water damaged due to a leaking vacuum valve. Thus the failure could be confirmed. Fsca-2018-07-18. This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary (b)(4) and further investigations and measures will be conducted in case of adverse trending. (b)(4).
 
Event Description
It was reported that the hcu 40 had a burning smell from the machine. (b)(4).
 
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Brand NameMAQUET HCU 40
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key8703381
MDR Text Key148157002
Report Number8010762-2019-00179
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHEATER COOLER UNIT
Device Catalogue Number701044054
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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