BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR PADS

    MDR report key: 14547605 · Received May 27, 2022

    Report

    Report Number
    MW5109980
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 26, 2022
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    UDI-DI
    00883873784938
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON COMPLETING A CARDIAC CARDIOVERSION STAFF NOTED SPARKS COMING FROM DEFIBRILLATOR PAD ON PATIENT'S CHEST. AFTER CARDIOVERSION COMPLETED UPON REMOVING PAD, PATIENT WAS LEFT WITH REDDENED BURNED AREA NEAR PAD PLACEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196504 DEFIBRILLATOR PADS AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. 11996-000090 204527 00883873784938

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization