BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091629 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00687
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 20, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DSI
    PMA / PMN Number
    993531
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS FOUND BURNT COMPONENTS IN THE POWER SUPPLY. POWER WAS REPLACED, UNIT WAS CALIBRATED, SAFETY TESTED, AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SMOKE WAS EMITTED FROM THE PASSPORT 2 MONITOR WHEN THE UNIT WAS POWERED ON. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186627 PASSPORT 2 MONITOR PATIENT MONITOR DSI MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1