BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1070611 · Received July 2, 2008

    Report

    Report Number
    3023750-2008-00164
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 2, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR. THE CUSTOMER RETURNED THE ACTUAL DEVICE INVOLVED FOR EVAL. FACTORY SERVICE CONFIRMED THE REPORTED DISPLAY FAILURE. THE EFFECT OF THE FAILURE IS THAT THE DEVICE WOULD NOT BE ABLE TO DISPLAY ECG SIGNALS OR OTHER SCREEN OUTPUT. FACTORY SERVICE ISOLATED THE DEFECT TO A FAILED MAIN PRINTED CIRCUIT BOARD. THEY REPLACED THE PRINTED CIRCUIT BOARD TO RESTORE OPERATION. AFTER MAIN BOARD REPLACEMENT THE DEVICE PASSED TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE SCREEN WENT BLANK DURING FLIGHT. THERE WERE NO PT COMPLICATIONS THAT RESULTED.

    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