BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA SERVER

    MDR report key: 2981032 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00041
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    011540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED CLEARING OF THE SYSTEM'S ERROR LOGS. THE SYSTEM RESTARTED AND COMMUNICATION REESTABLISHED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PANORAMA TELEMETRY SYSTEM SHUT DOWN, WHICH MAY HAVE RESULTED IN A LOSS OF TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38522 PANORAMA SERVER NONE MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1