BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUEST

    MDR report key: 752188 · Received July 18, 2005

    Report

    Report Number
    MW1036058
    Event Type
    Other
    Date Received
    July 18, 2005
    Date of Event
    June 30, 2005
    Report Date
    July 14, 2005
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF CABGX2, THE MYOCARDIAL PROTECTION SYSTEM-MPS-FAILED AND WAS UNABLE TO BE RESTARTED. AN EMERGENCY MANUAL PUMP WAS INSTALLED TO MAINTAIN CARDIOPLEGIA, HOWEVER THERE WAS A 7 MIN INTERRUPTION IN MYOCARDIAL PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST MPS MYOCARDIAL PROTECTION SYSTEM DTR QUEST MEDICAL, INC. UL60601-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other