BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE M1669A ECG TRUNK CABLE

    MDR report key: 7107648 · Received December 12, 2017

    Report

    Report Number
    7107648
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 2, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE INSPECTING THE BEDSIDE MONITORS, THE CLINICIAN NOTED EXCESSIVE DETERIORATION OF THE ECG TRUNK CABLE NEAR THE ECG LEAD CONNECTION POINT. RN NOTED THAT THE INSULATING COVER WAS "MELTING" AND SEPARATION OF THE CONNECTOR BODY COVERING. BIOMEDICAL CONTACTED AND ALSO CONFIRMED THAT THE CONNECTOR BODY WAS BEING DISSOLVED BY SOME CLEANING AGENT. BIOMEDICAL INSPECTED ADDITIONAL ECG TRUNK CABLES AND NOTED THE SAME PLASTIC BREAKDOWN OCCURRING. BIOMEDICAL CONTACTED EVS AND THE MANUFACTURER FOR ADVISE ON CLEANING AGENTS ALLOWED. BIOMEDICAL SUBSTITUTED WITH AN ALTERNATIVE ECG TRUNK CABLE THAT COULD BE USED WITHOUT DETERIORATING EFFECTS UNTIL CLEANING ISSUE/SUBSTANCE RESOLVED. MANUFACTURER RESPONSE FOR CABLE, ECG, TRUNK, 3-LEAD, INTELLIVUE (PER SITE REPORTER). AWAITING MANUFACTURER FEEDBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889557 INTELLIVUE M1669A ECG TRUNK CABLE CABLE, ELECTRODE IKD PHILIPS MEDICAL SYSTEMS M1669A

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEANING AGENTS.| NOT APPLICABLE.