BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDM NELLCOR

    MDR report key: 5101661 · Received September 24, 2015

    Report

    Report Number
    2124823-2015-00024
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K071073
    Removal / Correction Number
    Z-0648-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS FLUID CAN PASS THROUGH THE SEALS IN THE TOP COVER AND COME INTO CONTACT WITH ENERGIZED CONTACTS IN THE CIRCUIT BOARD. THIS CAN RESULT IN HEAT BUILDUP, SMOKE, AND DISCOLORATION. GE HEALTHCARE WILL PROVIDE A NEW TOP COVER. DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER HAD A PATIENT DATA MODULE WITH MELTED PLASTIC AND SIGNS OF OVERHEATING. NO PATIENT COMPROMISE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630909 PDM NELLCOR PHYSIOLOGICAL PATIENT MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. NA SA308145664GA

    Patients

    Seq Age Sex Outcome Treatment
    1