BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 WLAN

    MDR report key: 14711753 · Received June 16, 2022

    Report

    Report Number
    14711753
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 3, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS HSG
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED TO NURSING STAFF THAT THE BLACK EKG LEAD WIRE SET ON FIRE WHILE SHE WAS WEARING THE DEVICE. SHE WAS IN THE BATHROOM AND SMELLED SOMETHING STRANGE. SHE LOOKED DOWN AND SAW THE BLACK WIRE MELTING AND THEN A LITTLE FLAME APPEARED. SHE USED A WET TOWEL TO PUT IT OUT. THE PATIENT REPORTED NO INJURY AND NURSING STAFF VERIFIED NO BURN. THE PATIENT REPORTED EARLIER IN THE NIGHT SHE HAD NOTICED THAT THE TELEMETRY MONITOR BOX FELT HOT IN HER GOWN POCKET. SHE TOOK IT OUT OF HER GOWN AND LAID IT ON THE BED TO COOL OFF. THE PATIENT STATED THE BOX FELL OFF THE BED ONTO THE GROUND AT ONE POINT THAT EVENING. THE TELEMETRY BOX AND LEADS WERE SEQUESTERED AND DELIVERED TO BIOMEDICAL ENGINEERING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254553 INTELLIVUE MX40 WLAN MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS HSG MX40-WL3

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Unknown