BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1170335 · Received September 11, 2008

    Report

    Report Number
    3023750-2008-00215
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINTS WERE CONFIRMED, AND CAUSED BY CONTAMINATION FOUND INTERNAL TO THE BATTERY CIRCUIT BOARD CONNECTOR, AND ITS ASSOCIATED SOCKET. THIS CONTAMINATION GENERATED A WEAK ELECTRICAL CONNECTION REDUCING THE CIRCUIT VOLTAGE, WHICH, WITHOUT PROPER VOLTAGE, DID NOT ALLOW ACTIVATION OF A REQUIRED RELAY NECESSARY TO SEND THE ECG DATA FROM THE PATIENT PADS TO THE DEVICE. THE REDUCED CIRCUIT VOLTAGE ADDITIONALLY CAUSED THE CAPACITOR BANK NOT TO CHARGE COMPLETELY CAUSING THE REPORTED LESS THAN SELECTED ENERGY. REPLACEMENT OF THE CIRCUIT BOARD RESOLVED THE ISSUES. ONCE THE REPAIRS WERE MADE, THE DEVICE PERFORMS TO SPECIFICATIONS, AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THERE ARE NO ECG READINGS WHEN SET TO PAD AND USING PADS. ALSO, THE UNIT TESTS AT 200J, BUT SIMULATOR READS 138 JOULES. NO PATIENT INVOLVEMENT.

    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