BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091612 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00676
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 14, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPLACED THE SYSTEM'S HARD DRIVE AND RELOADED SYSTEM SOFTWARE. PERFORMED ALL FUNCTIONAL AND SAFETY CHECK AND UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION CORRUPT HARD DRIVE 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
    187156 PANORAMA CENTRAL STATION CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1