BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3813549 · Received March 26, 2014

    Report

    Report Number
    2221819-2014-00117
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    November 26, 2013
    Report Date
    November 27, 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

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD LOST COMMUNICATION, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176891 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL MONITORING SYSTEM MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK