• 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 AG MAQUET HCU30 DEVICE 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 AG MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 70103.4642
Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Patient Involvement (2645)
Event Date 12/31/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). A maquet field service technician will investigate and repair the device. A supplemental medwatch will be submitted when additional information becomes available.

 
Event Description

"no/low cooling capacity, no ice in the tank. " the incident occurred during maintenance / service, no patient was involved. (b)(4).

 
Manufacturer Narrative

(b)(4). The device was investigated by the service engineer at the depot. He could not repair the device there, so it was returned to the manufacturing site. The compressor, the main heater, the potentiometer and the bottom cover were all replaced. Function and safety tests were carried out as per service protocols. All tests passed and the device was shipped back to the customer. The customer has confirmed that the unit is functioning properly and that there are no problems. There was no patient involvement.

 
Event Description

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAQUET HCU30 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 Key5396623
MDR Text Key37617835
Report Number8010762-2016-00047
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number70103.4642
Device Catalogue NumberMCP00704631
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 Received01/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/13/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-