BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC FIBRILLATOR

    MDR report key: 1567150 · Received December 13, 2009

    Report

    Report Number
    1567150
    Event Type
    Malfunction
    Date Received
    December 13, 2009
    Date of Event
    November 17, 2009
    Report Date
    December 13, 2009
    Manufacturer
    PETER SCHIFF ENTERPRISE
    Product Code
    LIW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FIBRILLATOR PAD WAS PLACED DIRECTLY ON THE PATIENT'S HEART BY THE MD. THE PAD WAS PROPERLY CONNECTED TO THE FIBRILLATOR DEVICE BY THE RN, AND THEN TURNED TO FULL POWER AT THE MD'S REQUEST. NO POWER WAS DELIVERED TO THE PAD, ALTHOUGH, THE OUTPUT TEST LIGHT CAME ON. WE CHANGED OUT THE PAD AND TRIED THE DEVICE AGAIN, BUT THERE WAS STILL NO POWER DELIVERED TO THE PAD. THE CONNECTIONS WERE CHECKED WITH NO RESPONSE TO THE CHANGE. WE WERE NOT ABLE TO FIBRILLATE THE PATIENT USING THE FIBRILLATOR. WE HAD TO COOL TO FIBRILLATE. BIOMED VERIFIED THE PROBLEM WITH THE FIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC FIBRILLATOR FIBRILLATOR, AC LIW PETER SCHIFF ENTERPRISE 310C *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR