BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA TELEPACK

    MDR report key: 3172855 · Received May 21, 2013

    Report

    Report Number
    2221819-2013-00135
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    MINDARY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILED PANORAMA TELEPACK, WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225650 PANORAMA TELEPACK AMBULATORY TRANSMITTER MHX MINDARY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1