BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED 20

    MDR report key: 2463990 · Received February 14, 2012

    Report

    Report Number
    3023750-2012-01004
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Report Date
    January 25, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL AND A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE INTERMITTENTLY FAILED TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PT 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