• 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 HEATER COOLER UNIT 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 HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701034642 - HCU 30
Device Problems Insufficient Heating (1287); Temperature Problem (3022); Radiation Output Problem (4026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
(b)(4). It was reported that there was no circulation of cool water during operation. To complete the operation, they had to put hot water into the water tank to melt the ice block. No health damage to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEATER COOLER UNIT
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 Key9652827
MDR Text Key190536419
Report Number8010762-2020-00042
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number701034642 - HCU 30
Device Catalogue Number701034642
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/24/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-