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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701044054
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A maquet field service technician was on site and investigated the unit. The technician trouble shot the device and found a corroded shunt-valve which was responsible for the low water-flow. The technician cleaned and decalcified the corroded valve. Functional test and a test run were performed successfully.

 
Event Description

(b)(4). It was reported that during preventive maintenance the water-flow of the hcu30 was low. (b)(4).

 
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Brand NameMAQUET HCU40 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 Key5441841
MDR Text Key38988467
Report Number8010762-2016-00089
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number701044054
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 Received01/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2015
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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