BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III RESPIRATION GAS MONITOR

    MDR report key: 3091631 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00674
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 14, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    062754
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPLACED THE UNIT'S GAS MODULE BENCH. PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS AND UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE WHICH MAY HAVE RESULTED IN A LOSS OF GAS MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187688 GAS MODULE III RESPIRATION GAS MONITOR GAS MODULE BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1