BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III RESPIRATION GAS MONITOR

    MDR report key: 3091050 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00891
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 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

    MINDRAY SERVICE REPRESENTATIVES REPLACED THE SMALL DIAMETER TUBING BETWEEN THE O2 FILTER AND THE O2 SENSOR, ADJUSTED THE +5 AND +12 VOLT POWER SUPPLIES. PERFORMED A GAS CALIBRATION. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE GAS MODULE III FAILED WHICH MAY HAVE RESULTED IN A LOSS OF GAS MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186799 GAS MODULE III RESPIRATION GAS MONITOR GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1