BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS RESPIRATION MONITOR

    MDR report key: 3091159 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00944
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 25, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPS REPLACED THE GAS BENCH, TESTED AND CALIBRATED THE UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE GAS MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF GAS MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187916 GAS RESPIRATION MONITOR GAS MODULE II BZK MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1