BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 CONSOLE

    MDR report key: 794002 · Received November 30, 2006

    Report

    Report Number
    1649914-2006-00139
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 13, 2006
    Report Date
    November 29, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CASE, THE UNIT WOULD NOT DELIVER CARDIOPLEGIA WHEN THE FLOW KNOB WAS TURNED. THE PERFUSIONIST ALSO NOTICED THAT THE DELIVERY INDICATORS WERE NOT LIGHTING UP. THE UNIT WAS TURNED OFF THEN ON SEVERAL TIMES BEFORE GETTING THE UNIT TO DELIVER; THE CASE WAS THEN FINISHED SUCCESSFULLY. THE UNIT WILL BE RETURNED. PRODUCT CODE 5201260.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS2 CONSOLE CARDIOPLEGIA DELIVERY SYSTEM--HARDWARE DTR QUEST MEDICAL, INC. 5201260 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN