BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010042-2008-00046

    MDR report key: 1028956 · Received April 4, 2008

    Report

    Report Number
    8010042-2008-00046
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Product Code
    CBK
    PMA / PMN Number
    K970839
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PROD FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1