BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 6 MONITOR

    MDR report key: 3264093 · Received July 31, 2013

    Report

    Report Number
    2221819-2013-01432
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 28, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REP REPLACED WATER TRAP AND CALIBRATED THE UNIT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO O2 READING FROM THE DPM 6 MONITOR. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358277 DPM 6 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1