BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARQUETTE

    MDR report key: 197650 · Received November 16, 1998

    Report

    Report Number
    MW1014979
    Event Type
    Other
    Date Received
    November 16, 1998
    Date of Event
    May 1, 1998
    Report Date
    November 13, 1998
    Manufacturer
    MARQUETTE MEDICAL SYSTEMS, INC.
    Product Code
    DPS
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED STINGING AT THE NUMBER 2 LEAD SITE OF THE EKG MACHINE WHEN THE MACHINE STARTED. EKG MACHINE REMOVED FROM PT AND SAMLL RED AREA NOTED ON THE LEFT BREAST OF PT BUT QUICKLY FADED. NO EVIDENCE OF BURN OR INJURY AT SITE. BIOMED EVALUATED MACHINE, FOUND NO MALFUNCTION AND RETURNED MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE EKG MACHINE DPS MARQUETTE MEDICAL SYSTEMS, INC. MAC PC *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other