BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK COMBO PAD

    MDR report key: 62903 · Received January 17, 1997

    Report

    Report Number
    MW1010574
    Event Type
    Injury
    Date Received
    January 17, 1997
    Date of Event
    January 7, 1997
    Report Date
    January 10, 1997
    Manufacturer
    PHYSIO CONTROL CORP.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED 1/5/97 WITH RESPIRATORY DISTRESS AND LETHARGY. DIAGNOSED WITH PNEUMONIA, UTI, PROBABLE SEPSIS. ON 1/7/97 AT APPROX 3 AM, PT ARRESTED AND WAS DEFIBRILLATED 3 TIMES. ON 4TH DEFIBRILLATION, PUFF OF SMOKE AND ARC OBSERVED. PT SUSTAINED SKIN BURN. DEFIBRILLATED A 5TH, 6TH, AND 7TH TIME BEFORE DISCONTINUED THE USE OF THE PADDLE. PT ARRESTED AROUND 10 AM ON 1/7 AND CEASED TO BREATH. CAUSE OF DEATH DETERMINED TO BE CARDIAC ARREST. NO AUTOPSY PERFORMED. ADD'L LOT # K080296.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK COMBO PAD Implant ELECTRODE/PAD MLN PHYSIO CONTROL CORP. LIFEPACK 9/P QUICK COMBO PADS K092596,K072296-5,K090496-12

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening LIFEPACK 9-P SERIAL #015153