BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1193424 · Received October 8, 2008

    Report

    Report Number
    3015876-2008-01470
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS WORKING ON A PATIENT WITH AN IMPLANTED DEFIBRILLATOR (ICD) WHEN THEY ATTEMPTED THREE SHOCKS WITH THE IMPLANTABLE DEVICE, AND IT WOULD NOT CONVERT. THE MEDICAL PERSONNEL THEN DISABLED THE ICD AND USED THE LP20 DEVICE TO DELIVER ONE SHOCK OF 360 JOULES, WHICH CONVERTED THE PATIENT. THREE SECONDS AFTER THE ENERGY WAS DELIVERED, THERE WAS A SLIGHT DEFLECTION, AND THE CUSTOMER BELIEVE IT WAS A SHOCK. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK