BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091513 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00462
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 19, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES REPLACED THE UNIT BENCH ASSEMBLY. UNIT WAS CALIBRATED AND TESTED TO PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO O2 READINGS ON THE GAS MODULE II WHICH MAY HAVE RESULTED IN A LOSS OF O2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186441 GAS MODULE II GAS MONITOR BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1