BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1051203 · Received May 23, 2008

    Report

    Report Number
    3023750-2008-00135
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 6, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINTS OF ECG ARTIFACT, INCORRECT HEART RATE AND PACER SPIKES WERE CONFIRMED AND ALL CAUSED BY A WEAK CONNECTION BETWEEN A CABLE AND ITS CONNECTOR ON THE PREAMP CIRCUIT BOARD. THE CONNECTOR WAS REMOVED AND THE CABLE WAS SOLDERED DIRECTLY TO THE CIRCUIT BOARD PER PRESENT PROCESS TO RESOLVE THE ISSUE. UPON COMPLETION OF REPAIRS, THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATES ECG ARTIFACTS, INCORRECT HEART RATE AND PACER SPIKES DISPLAYED WHEN ATTACHED TO A PT AND NOT PACING. NO HARM TO PT.

    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 71 YR