BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 6372922 · Received March 2, 2017

    Report

    Report Number
    1649914-2017-00009
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 6, 2017
    Report Date
    May 19, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624501007
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CONSOLE CONFIRMED THE REPORTED ISSUE. THE MOTOR DRIVER BOARD WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. THE CONSOLE THEN SUCCESSFULLY PASSED ALL VERIFICATION TESTING AND WAS RELEASED BACK FOR USE.

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE WITH THE MPS CONSOLE DURING USE. SHE REPORTED THAT THE CONSOLE ALARMED AND DISPLAYED AN ERROR CODE FOR "INTERNAL TIMING ERROR" DURING THE INDUCTION DOSE OF ARREST AGENT. THE REPORT STATED THAT THE CONSOLE DISPLAYED THE ERROR FOUR TIMES BEFORE REMAINING ON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153529 MYOCARDIAL PROTECTION SYSTEM CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001000 20634624501007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention