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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 70102.8718
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/31/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device is being returned to the repair depot. A maquet field service technician will investigate the unit. A supplemental medwatch will be submitted as soon as additional information becomes available.

 
Event Description

It was reported that the ice block had filled the entire tank, indicating a bad ice sensor. No patient was involved, the malfunction was detected during maintenance / service. (b)(4).

 
Manufacturer Narrative

(b)(4). A maquet field service technician investigated the unit and replaced a shorted compressor and fan. A defective connector female 3/8" was also replaced. The unit was charged with freon. Preventive maintenance, functional test and safety check as per the service manual were performed successfully.

 
Event Description

(b)(4).

 
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Brand NameMAQUET HCU30 DEVICE
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
4972229321
MDR Report Key5398894
MDR Text Key37714963
Report Number8010762-2016-00052
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number70102.8718
Device Catalogue Number70102.8718
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Ageyr
Event Location No Information
Date Manufacturer Received05/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2005
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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