BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091761 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00601
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 31, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SERVICE REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S HARD DRIVES AND POWER ADAPTER CABLES. THE SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187971 PANORAMA CENTRAL STATION PATIENT MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1