BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM

    MDR report key: 1082698 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08062
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 14, 2008
    Manufacturer
    EDWRDS LIFESCIENCES
    Product Code
    DQO
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE, THE EQUIPMENT SHOWED ONE CONNECTION BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM BLOOD SAMPLING KIT DQO EDWRDS LIFESCIENCES VMP106 58416506

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK