BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE EKG LEADWIRES

    MDR report key: 11626822 · Received April 7, 2021

    Report

    Report Number
    11626822
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 5, 2021
    Manufacturer
    MEDICAL ACCESSORIES AND CABLES
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE COMPLAINTS FOR CARDIOLOGY DEPARTMENT THAT EKG ARE NOT READABLE OR HAVE DIFFERENT OUTPUT. EMERGENCY DEPARTMENT NOTIFIED CLINICAL ENGINEERING. DURING THE CLINICAL ENGINEERING INVESTIGATION, WE FOUND OUT THAT THE LEADS THAT WERE USED ARE FROM A THIRD PARTY (MEDICAL ASSOCIATES AND CABLES). WE FOUND OUT THAT THE DIAMETER OF THE LEADS IS TOO SMALL COMPARED TO THE DIAMETER OF THE GE CABLE. THE CABLE WAS TOO LOOSE CAUSING INTERMITTENT OR WRONG EKG OUTPUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525233 GE HEALTHCARE EKG LEADWIRES CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA MEDICAL ACCESSORIES AND CABLES GE CA14 UNIVERSAL COMPATIBLE CABLE 1200317076

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA