BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091106 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00935
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES REPLACED THE UNITS O2 CELL AND NATION TUBING, PERFORMED UNIT CALIBRATION, FUNCTION, AND SAFETY CHECKS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE GAS MODULE FREEZES DURING USE WHICH MAY HAVE RESULTED IN A LOSS OF GAS MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187035 GAS MODULE II GAS MONITOR BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1