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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 Problems Excessive Cooling (2932); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2019
Event Type  Malfunction  
Manufacturer Narrative

The technician was on side to perform initial investigation of the device in question. The technician performed a defrosting and emptying the tank. After that the ice bildung was performed again without any issues. The ice building was fine. A supplemental medwatch will be submitted if additional information becomes available. (b)(4).

 
Event Description

It was reported that the ice block of the hcu 40 was too big. No patient was involved. Complaint # (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 Key8734617
MDR Text Key149210008
Report Number8010762-2019-00191
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
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 07/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberHEATER COOLER UNIT
Device Catalogue Number701044054
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/23/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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