BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED 20

    MDR report key: 2503216 · Received March 14, 2012

    Report

    Report Number
    3023750-2012-01008
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Report Date
    February 23, 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 DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DISCHARGE. 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