BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III MONITOR

    MDR report key: 3091791 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01083
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BZK
    PMA / PMN Number
    062754
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND FOUND A KINKED TUBE. TUBE WAS REPAIRED AND UNIT WAS CALIBRATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENT PROBLEMS WITH AN AIR LEAK ON THE GAS MODULE III, WHICH MAY HAVE AFFECTED GAS MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188171 GAS MODULE III MONITOR GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1