BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED10

    MDR report key: 2113003 · Received May 25, 2011

    Report

    Report Number
    3023750-2011-01083
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 3, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    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 A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE UNIT RESTARTS/REBOOTS BY ITSELF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA