BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM 9000 EXPRESS MONITOR

    MDR report key: 3091058 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00796
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVE REPLACED THE UNITS TUBING AND WATER RECEPTACLE. CALIBRATED CO2. FUNCTIONAL AND SAFETY TESTED TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PM 9000 EXPRESS MONITOR WHICH MAY HAVE AFFECTED CO2 READINGS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188223 PM 9000 EXPRESS MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1