BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091644 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00649
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 5, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS UPGRADED THE SYSTEM SOFTWARE AND REPLACED THE CD DRIVE AND CPU BOARDS AS PREVENTATIVE MEASURES. PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS AND SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION, WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186807 PANORAMA CENTRAL STATION CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1