BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III

    MDR report key: 3091423 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00446
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 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 TUBING BETWEEN THE O2 FILTER AND THE O2 SENSOR AND THE WATER TRAP AND PUMP AND RESOLVED THE ISSUE. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE III 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
    186611 GAS MODULE III GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1