BEUDAMED
    FDA Adverse Event Summary report: N

    DEFIBRILLATOR

    MDR report key: 32415 · Received April 29, 1996

    Report

    Report Number
    MW4001164
    Date Received
    April 29, 1996
    Date of Event
    January 1, 1994
    Report Date
    February 26, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO CORRESPONDENCE FORWARDED BY RPTR, COMPLAINANTS' MEDICS COMPLAIN ALMOST DAILY IN REGARD TO THE AMOUNT OF ARTIFACT THEY ARE SEEING. MOST RECENTLY THEY HAVE HAD TWO CPR SITUATIONS THAT BATTERIES HAVE GONE DEAD, AND MEDICS HAD TO TAKE THE TIME TO REPLACE THEM. COMPLAINANT IS RECEIVING COMPLAINTS FROM PERSONNEL WHO FEEL THAT THEY ARE ASSUMING A GREAT DEAL OF LIABILITY, USING EQUIPMENT THEY KNOW IS DIFFICULT TO WORK WITH. PERSONNEL C/O A PROBLEM WITH THE ECG SIZE BUTTON. WHEN IT IS PUSHED THE RESPONSES ARE INAPPROPRIATE. RPTR ALSO FORWARDED CORRESPONDENCE INDICATING MFR'S RESPONSE TO THEIR COMPLAINTS HAS BEEN INADEQUATE. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR DEFIBRILLATOR LDD MARQUETTE ELECTRONICS, INC. 1500

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO