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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 70104.4054
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Excessive Cooling (2932)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Reference exemption # (b)(4). Importer- (b)(4).

 
Event Description

According to the customer: it was reported that the tank was frozen. Additional information: the incident occurred during patient treatment. Ref. : (b)(4). Customer ref. : n/i.

 
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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 Key8264695
MDR Text Key133837169
Report Number8010762-2019-00015
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number70104.4054
Device Catalogue Number70104.4054
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2018
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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