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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701044054 - HCU 40
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2019
Event Type  Malfunction  
Manufacturer Narrative

The field service technician was onsite. The device board was changed. The exchange didn't solve the problem. It was detected that the power supply unit was broken. The replacement of the power supply unit is ongoing. Further evaluation still in progress. When further information becomes available a follow up medwatch will be submitted.

 
Event Description

It was reported that the hcu 40 had a defective device board. Complaint#(b)(4).

 
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Brand NameHEATER COOLER UNIT
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 Key8997073
MDR Text Key199891537
Report Number8010762-2019-00281
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK031554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number701044054 - HCU 40
Device Catalogue Number701044054
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/24/2015
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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