BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 6 MPM MODULE

    MDR report key: 2981048 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00051
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    June 14, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION INCLUDED REPLACEMENT OF DPM 6 MPM MODULE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RESPIRATION RATE ON THE DPM 6 MONITOR IS NOT FUNCTIONAL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39909 DPM 6 MPM MODULE NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1