BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091310 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00372
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 4, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DSI
    PMA / PMN Number
    020550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVE REPLACED THE PASSPORT MONITOR'S CO2 BOARD, REPROGRAMMED, CALIBRATED AND SAFETY TESTED THE UNIT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PASSPORT 2 MONITOR'S CO2 FUNCTION WAS NOT WORKING WHICH MAY HAVE RESULTED IN A LOSS OF CO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187345 PASSPORT 2 MONITOR PATIENT MONITOR DSI MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1