BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 6

    MDR report key: 2981046 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00048
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    April 19, 2011
    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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS INCLUDED REPLACEMENT OF THE UNIT'S MPM MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A PATIENT WAS BEING MONITORED ON THE DPM 6 MONITOR, THE UNIT SHUT DOWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38724 DPM 6 NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1