BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, NEONATAL

    MDR report key: 39854 · Received September 27, 1996

    Report

    Report Number
    MW4001517
    Event Type
    Malfunction
    Date Received
    September 27, 1996
    Report Date
    July 10, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT MONITOR FREQUENTLY ALARMING "LEADS FAIL", SHOWS ARTIFACT DESPITE RE-WETTING AND REPOSITIONING. POOR TRACING OR BAD CONDUCTION AND DO NOT STICK WELL TO INFANTS. LEAD WIRES HAD TO BE REPLACED MUCH MORE OFTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, NEONATAL ELECTRODE DRX MARQUETTE ELECTRONICS, INC. TD-60158 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *