BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091073 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00872
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS SUA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND EXCESSIVE HEAT IN THE RACK ROOM. CUSTOMER WAS PROVIDED WITH A LOANER SYSTEM, WHICH INCLUDED THE SERVER, WIRELESS TRANSCEIVER, TIM, AND SWITCH, WHICH IT IS BEING RETURNED TO MINDRAY'S NATIONAL REPAIR CENTER FOR REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION SHUT DOWN, 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
    186976 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS SUA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1