BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT DATA MODULE

    MDR report key: 2092163 · Received April 27, 2011

    Report

    Report Number
    2124823-2011-00049
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K071073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SMOKE SMELL IN THE PT'S ROOM AND THEY FOUND THE PT DATA MODULE (PDM) WITH A HOLE IN THE MIDDLE OF THE PLASTIC CASE. THE PLASTIC HAD STARTED TO MELT. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT, NOR WAS MEDICAL INTERVENTION REQUIRED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT DATA MODULE PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1