BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091834 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01035
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 16, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE GAS BENCH.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187081 GAS MODULE II GAS MONITOR BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1