BEUDAMED
    FDA Adverse Event Summary report: N

    PANORAMA CENTRAL STATION/TELEPACK

    MDR report key: 3092099 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00235
    Date Received
    April 30, 2013
    Date of Event
    August 16, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED RESETTING THE WIRELESS TRANSCEIVER AND SERVER. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS, IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOSS OF COMMUNICATION BETWEEN THE PANORAMA TELEPACKS AND THE PANORAMA CENTRAL STATION, RESULTING IN A POSSIBLE LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187259 PANORAMA CENTRAL STATION/TELEPACK CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC. 0998-00-0700-XX

    Patients

    Seq Age Sex Outcome Treatment
    1