BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1003247 · Received February 21, 2008

    Report

    Report Number
    3023750-2008-00057
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: (DEVICE PERFORMS TO SPECIFICATIONS). THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. DURING A FACTORY SVC REPAIR, THE TECH IDENTIFIED A SINGLE PREAMP REFERENCE FAILURE ERROR CODE ENTRY IN THE DEVICE LOG. TESTING DOES NOT INDICATE ANY FAILURE OR MALFUNCTION OF THE DEVICE (RESULT CODE). THE INVESTIGATION REVEALED THAT THE DEVICE PERFORMS TO SPECIFICATIONS (CONCLUSION CODE). CAUSE OF THE ERROR CODE IN THE DEVICE LOG IS INCONCLUSIVE. THE DEVICE WAS UPGRADED, TESTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH FACTORY SVC FINDINGS THAT THE UNIT HAD A "PREAMP EXT. REFERENCE FAIL" ERROR CODE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED10

    Patients

    Seq Age Sex Outcome Treatment
    1