BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-541PA

    MDR report key: 4173576 · Received September 10, 2014

    Report

    Report Number
    8030229-2014-00047
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Product Code
    DRT
    PMA / PMN Number
    K043517
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING REQUESTED DEVICE FOR REPAIR AND FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559740 ZM-541PA TELEMETRY TRANSMITTER DRT

    Patients

    Seq Age Sex Outcome Treatment
    1