BEUDAMED
    FDA Adverse Event Other Summary report: N

    FR2

    MDR report key: 1743589 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00244
    Event Type
    Other
    Date Received
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. RESULT: ECG PRESENT DURING ANALYSIS. DEVICE LABELING AND VOICE PROMPTS PROVIDE INSTRUCTIONS ON HOW TO ADDRESS ARTIFACTS. CONCLUSION: THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUDED THAT RECURRENCE WILL NOT RESULT IN A DELAY OF THERAPY.

    Description of Event or Problem · 1

    ARTIFACT PRESENT DURING AED DEPLOYMENT. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3860A-ABU

    Patients

    Seq Age Sex Outcome Treatment
    1