BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091460 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00358
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 27, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACING THE GAS BENCH AND CALIBRATING THE UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GAS MODULE II WON'T TAKE GAS READINGS. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187029 GAS MODULE II GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1