BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED10

    MDR report key: 1935073 · Received December 3, 2010

    Report

    Report Number
    3023750-2010-01236
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 11, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INAPPROPRIATELY SHUT DOWN. 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