BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091142 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00613
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 11, 2012
    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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES ADJUSTED THE POWER SUPPLY AND REPLACED SYSTEM TUBING AND FILTERS. PERFORMED CALIBRATION AND FUNCTIONAL TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENT GAS READINGS FROM THE GAS MODULE II WHICH MAY HAVE RESULTED IN AN INTERMITTENT LOSS OF GAS MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187158 GAS MODULE II GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1