BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISA CENTRAL MONITORING STATION

    MDR report key: 3091454 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00377
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 30, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    DSI
    PMA / PMN Number
    913576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP INSPECTED THE ROOM WHERE THE CENTRAL STATION AND BEDSIDE MONITOR ARE LOCATED AND FOUND OBJECTS ON TOP OF THE TOWER AND LOSE CABLES. CABLES WERE RESEATED AND COMMUNICATION REESTABLISHED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VISA CENTRAL MONITORING STATION HAD LOST DATA, WHICH MAY HAVE RESULTED IN LOSS OF TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186990 VISA CENTRAL MONITORING STATION CENTRAL MONITORING STATION DSI MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1