BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3231725 · Received July 12, 2013

    Report

    Report Number
    2221819-2013-01434
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    January 22, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S WIRELESS TRANSCEIVER (TIM).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD LOST COMMUNICATION, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322520 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1