BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091657 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00672
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 8, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    031760
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPAIRED A BROKEN LATCH AND CALIBRATED MODULES TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA TELEPACK SPO2 MODULES WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY SPO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188196 PANORAMA CENTRAL STATION CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1