BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 510

    MDR report key: 173532 · Received June 19, 1998

    Report

    Report Number
    1216774-1998-00009
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Report Date
    June 16, 1998
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR IDENTIFIED AND ISOLATED ALL MODELS AND SERIAL NUMBERS OF THIS MONITOR TYPE CONTAINING A SPECIFIC (EAGLE PITCHER) VENDOR BATTERY KNOWN TO HAVE THE POTENTIAL OR LEAKING ELECTROLYTE. THIS MONITOR WAS STOCKED AS DEMO CONTAINING THIS SPECIFIC BATTERY, WAS OPENED, AND BATTERY WAS CONFIRMED TO BE MADE BY EAGLE PITCHER. CORROSION FROM THE ELECTROLYTE WAS VISUALLY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 510 INFANT MONITOR FLS COROMETRICS MEDICAL SYSTEMS, INC. 510 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other