BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010762-2008-00001

    MDR report key: 1015267 · Received February 20, 2008

    Report

    Report Number
    8010762-2008-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY. MAQUET CARDIOPULMONARY PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTQ

    Patients

    Seq Age Sex Outcome Treatment
    1