• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HEATER COOLER UNIT
Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 10/15/2019
Event Type  Malfunction  
Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

 
Event Description

Complaint number (b)(4). It was reported that hcu30 stopped the circulation of the piping when the water temperature was raised from the 21 ° c setting.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9248968
MDR Text Key200465824
Report Number8010762-2019-00340
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHEATER COOLER UNIT
Device Catalogue NumberHCU 30, 701028718
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 Received01/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/29/2019 Patient Sequence Number: 1
-
-