BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1203128 · Received October 9, 2008

    Report

    Report Number
    3023750-2008-00227
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OTHER ( FERRITE BEAD SHIFTING OUT OF ITS NORMAL PATH AND COMING IN CONTACT WITH THE CABLE). EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINT WAS CONFIRMED AND CAUSED BY A CABLE PARTIALLY PULLING OUT OF ITS CONNECTOR (RESULT CODES 423 & 435) GENERATING ECG NOISE. THIS SEPARATION WAS DUE TO A FERRITE BEAD SHIFTING OUT OF ITS NORMAL PATH (RESULT CODE 100) AND COMING IN CONTACT WITH THE CABLE. PROPER ROUTING OF THE FERRITE BEAD AND REINSERTION OF THE CABLE RESOLVED THE FAILURE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE DEVICE HAS NOISE ON THE ECG TRACE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR