BEUDAMED
    FDA Adverse Event Other Summary report: N

    AED

    MDR report key: 1416707 · Received May 15, 2009

    Report

    Report Number
    3023750-2009-00171
    Event Type
    Other
    Date Received
    May 15, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 16, 2009
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT ADDITIONAL TIME IS REQUIRED TO COMPLETE THE ANALYSIS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER AED 10 TRAINING DEVICE HAS A RUPTURED BATTERY CELL. NO PT INVOLVEMENT - A TRAINING DEVICE DOES NOT CONTAIN DEFIBRILLATION CIRCUITRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED 10 TRAINING

    Patients

    Seq Age Sex Outcome Treatment
    1