BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3102686 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01036
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 18, 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
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE SYSTEM AND FOUND THE SYSTEM SOFTWARE WAS CORRUPTED. CORRECTIONS INCLUDED RELOADING OF THE SYSTEM'S SOFTWARE. SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION SHUT DOWN AFTER THE FACILITY'S GENERATOR POWER FAILURE, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190720 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1