BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 CONSOLE

    MDR report key: 773330 · Received August 14, 2006

    Report

    Report Number
    1649914-2006-00071
    Event Type
    Malfunction
    Date Received
    August 14, 2006
    Date of Event
    July 25, 2006
    Report Date
    August 14, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING CARDIOPLEGIA DELIVERY, THE UNIT TURNED OFF UNEXPECTEDLY DURING CASE. THE UNIT WAS POWERED ON AGAIN AND THE DELIVERY OF CARDIOPLEGIA CONTINUED WITHOUT FURTHER INCIDENT. THE UNIT WILL BE RETURNED TO QUEST FOR FURTHER INCIDENT. THE UNIT WILL BE RETURNED TO QUEST FOR FURTHER EVALUATION. 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