BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 7 / MPM MODULE

    MDR report key: 3172850 · Received May 21, 2013

    Report

    Report Number
    2221819-2013-00124
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    August 12, 2011
    Report Date
    February 28, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILED MPM MODULE ON THE DPM 7 MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225624 DPM 7 / MPM MODULE PT MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1