BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDM

    MDR report key: 5067921 · Received September 10, 2015

    Report

    Report Number
    2124823-2015-00020
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 14, 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

    NO PATIENT INVOLVEMENT. EVENT DATE: INCIDENT DATE UNKNOWN. 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. THIS IS RELATAED TO CORRECTION REPORT Z-0648-2014. CUSTOMERS WERE PROVIDED SAFETY INSTRUCTIONS VIA URGENT MEDICAL DEVICE CORRECTION LETTER. GE HEALTHCARE WILL PROVIDE A NEW TOP COVER AT NO CHARGE. THIS CORRECTION HAS NOT YET BEEN APPLIED TO THE REPORTED DEVICE.

    Description of Event or Problem · 1

    THE PATIENT DATA MODULE (PDM) WAS INSTALLED IN THE DOCK OF A B850 MONITOR. SHORTLY AFTER SMOKE, NO FLAMES, STARTED TO COME FROM THE PDM. THE PDM WAS REPLACED WITH ANOTHER AND THE DOCK/B850 WORKED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598650 PDM MONITOR, PHYSIOLOGICAL, PATIENT MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. PDM SA309365201GA

    Patients

    Seq Age Sex Outcome Treatment
    1