BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX

    MDR report key: 1743445 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00200
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    October 25, 2009
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ECG AND INTERNAL MEMORY RELATED TO THE INCIDENT WAS REVIEWED. RESULTS: ARTIFACTS PRESENT THROUGHOUT ANALYSIS. CONCLUSION: DEVICE LABELING, (INSTRUCTIONS FOR USE AND VOICE PROMPTS) PROVIDE INSTRUCTIONS FOR RESOLVING ARTIFACTS.

    Description of Event or Problem · 1

    ARTIFACTS WERE PRESENT DURING AED DEPLOYMENT, SUBJECT WAS NOT RESUSCITATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRX AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM 989803146811

    Patients

    Seq Age Sex Outcome Treatment
    1 Death