BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3102690 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01041
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 5, 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
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THAT ALL THE PATIENTS HAD BEEN DISCHARGED AND THE SYSTEM APPEARED TO BE OPERATING NORMALLY. SYSTEM WAS REBOOTED AND TESTED FOR TELEMETRY COMMUNICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOSS OF COMMUNICATION BETWEEN THE PANORAMA CENTRAL STATION AND PANORAMA. TELEPACKS, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190281 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1