BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION

    MDR report key: 11752122 · Received April 30, 2021

    Report

    Report Number
    11752122
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 23, 2021
    Manufacturer
    ZOLL MEDICAL
    Product Code
    MTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMING OFF BYPASS, PATIENT WITH V-FIB , SURGEON WANTED TO SHOCK WITH INTERNAL DEFIB PADDLES, DEFIB PADDLES CHARGED , SURGEON UNABLE TO DELIVER SHOCK WITH PADDLES. DEFIBRILLATOR MACHINE TESTED IN THE MORNING (AM), INTERNAL DEFIBRILLATOR PADDLES NOT TESTED DURING CASE. SHOCKED PATIENT WITH EXTERNAL PADDLES, CONVERTED TO NORMAL SINUS RHYTHM, NO FURTHER INTERVENTION FOR DEFIBRILLATOR NEEDED. INTERNAL DEFIBRILLATOR PADDLES SEQUESTERED. INTERNAL PADDLES SENT TO BIOMEDICAL ENGINEERING FOR TESTING AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654252 SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION MTE ZOLL MEDICAL 8011-1050-01

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA