BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS RESPIRATION MONITOR

    MDR report key: 3091160 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00941
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    BZK
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPS REPLACED THE UNITS GAS BENCH, TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    LOSS OF GAS MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187261 GAS RESPIRATION MONITOR GAS MODULE II BZK MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1