BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA TIM

    MDR report key: 2981035 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00044
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 12, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. THE CUSTOMER WAS PROVIDED WITH A LOANER WIRELESS TRANSCEIVER (TIM) WHILE THE UNIT IS BEING RETURNED TO THE FACTORY FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE WIRELESS TRANSCEIVER (TIM) HAD LOST COMMUNICATION WITH THE PANORAMA CENTRAL STATION, WHICH MAY HAVE RESULTED IN A LOSS OF TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38523 PANORAMA TIM NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1