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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 MCP00704629
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A maquet field service technician was on site and investigated the unit. The technician troubleshot the device but was not able to duplicate or confirm the error messages. The system was tested for electrical safety and functionality. All tests were completed per factory specifications. A supplemental medwatch will be submitted if additional informations becomes available.

 
Event Description

It was reported that the hcu30 began to alarming after 5 minutes on patient treatment. (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
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key5676635
MDR Text Key46011993
Report Number8010762-2016-00352
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
Report Date 05/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCP00704629
Device Catalogue Number701034371
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 Received06/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2006
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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