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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HCU 30
Device Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
It was reported that the hcu 30 heats up very slowly during treatment. No indication of actual or potential for harm or death. (b)(4).
 
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Brand NameHEATER COOLER UNIT HCU 30
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 Key10884742
MDR Text Key217680257
Report Number8010762-2020-00397
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K031544
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,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHCU 30
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Yes
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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