BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 CONSOLE

    MDR report key: 717903 · Received May 16, 2006

    Report

    Report Number
    1649914-2006-00043
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    April 5, 2006
    Report Date
    May 4, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CONSOLE APPEARED TO LEAK WATER. THE CONSOLE WAS USED FOR THE REMAINING OF THE CASE WITHOUT FURTHER INCIDENT. PRODUCT CODE IS 5201260, SERIAL 2005.

    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 *