BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091405 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00439
    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
    DSI
    PMA / PMN Number
    993531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPLACED THE SPO2 BOARD AND REPROGRAMED THE UNIT. CALIBRATED AND SAFETY TESTED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT 2 MONITOR, WHICH MAY HAVE RESULTED IN INTERMITTENT SPO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186583 PASSPORT 2 MONITOR PATIENT MONITOR DSI MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1