BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION W/TELEPACK

    MDR report key: 3091117 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00817
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 15, 2013
    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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPRESENTATIVE ADVISED THE CUSTOMER TO RUN A DIAGNOSTIC TEST, RELOADED AND RECONFIGURED THE SYSTEM'S HARD DRIVE. OPERATION WAS VERIFIED AND THE SYSTEM WORKED PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION KEPT REBOOTING, WHICH MAY HAVE RESULTED IN LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187751 PANORAMA CENTRAL STATION W/TELEPACK CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1