BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED 20

    MDR report key: 1911327 · Received November 22, 2010

    Report

    Report Number
    3023750-2010-01227
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 5, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND FOLLOW-UP REPORT WILL BE PROVIDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED 20 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. AED20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA