BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091628 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00686
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 16, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DSI
    PMA / PMN Number
    020550
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPLACED THE MONITOR'S MAIN BOARD. COMPLETED FUNCTIONAL AND SAFETY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT 2 MONITOR THAT MAY HAVE CAUSED THE MONITOR TO SHUT DOWN, POSSIBLY RESULTING IN A LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187687 PASSPORT 2 MONITOR PATIENT MONITOR DSI MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1