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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LP CARDIOQUIP CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP, LP CARDIOQUIP CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000 I
Device Problems Loose or Intermittent Connection (1371); Melted (1385); Overheating of Device (1437); Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2017
Event Type  Malfunction  
Event Description

At the beginning of the case, the heater cooler unit would not turn on. Investigation found the screws inside the ac power plug were loose and one had overheated and melted the plug. The plug was damaged beyond repair and needed to be replaced. We have a total of 6 machines. After finding this, the other machines were inspected. The screws on all 5 remaining machines were extremely loose and one had a partially melted wire. Screws were tightened on all machines.

 
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Brand NameCARDIOQUIP
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP, LP
3827 old college rd
bryan TX 77801
MDR Report Key6982910
MDR Text Key90411981
Report Number6982910
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000 I
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2017
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer10/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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