BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091425 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00750
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 11, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES REPLACED CAPACITORS ON THE UNIT'S MOTHERBOARD, A MISSING POWER SUPPLY, RAN DIAGNOSTIC TESTS. CALIBRATED, AND SAFETY CHECKED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMWER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION, 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
    186846 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1