BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM 9000 EXPRESS

    MDR report key: 3091742 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00729
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    070791
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REP REPLACED THE MOISTURE EXCHANGE TUBING AND THE GAS MODULE. COMPLETED FUNCTIONAL AND SAFETY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PM-9000 MONITOR WHICH MAY HAVE RESULTED IN A LOSS OF ETC02 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187149 PM 9000 EXPRESS PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1