BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1063822 · Received June 19, 2008

    Report

    Report Number
    3023750-2008-00155
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 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

    MFR'S EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR. THE USER RETURNED THE ACTUAL DEVICE FOR EVAL. THE USER REPORTED ECG COMM ERRORS ON POWER UP, RENDERING THE DEVICE UNUSABLE. THE USER INDICATED THAT TREATMENT WAS NOT DELAYED AND THE PT NOT INJURED BECAUSE OF THE MALFUNCTION. FACTORY SERVICE DUPLICATED THE REPORTED ECG COMM ERROR. WE ISOLATED THE CAUSE OF THE FAILURE TO INTEGRATED CIRCUIT CHIP U2 ON THE PREAMP BOARD OF THE DEVICE. VISUAL EXAMINATION OF THE COMPONENT CHIP UNDER MAGNIFICATION REVEALED THAT THE CHIP HAD BECOME PARTIALLY DISCONNECTED FROM ITS SOCKET. WE RE-INSERTED THE CHIP INTO THE SOCKET AND RESTORED NORMAL OPERATION. NONETHELESS, WE REPLACED THE PREAMP BOARD WITH A LATER VERSION BOARD WITHOUT A SOCKETED CONNECTION, WHICH WILL ENSURE GREATER RELIABILITY OF THE U2 CONNECTION. SUBSEQUENTLY, THE DEVICE PASSED ALL ACCEPTANCE TESTING AND WE RETURNED IT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THERE WAS AN ECG COM ERROR AT POWER UP. THEY USED ANOTHER UNIT TO TREAT THE PT. NO HARM TO THE PT DUE TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC50

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR