BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1728359 · Received June 16, 2010

    Report

    Report Number
    3030677-2010-00076
    Event Type
    Death
    Date Received
    June 16, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INTERNAL MEMORY AND ECG RELATED TO USE REVIEWED. RESULTS: ARTIFACT NOTED. CONCLUSION: THIS REPORT IS BEING FILED DUE TO PT DEATH. AED LABELING (IFU AND VOICE PROMPTS) PROVIDE USER WITH INSTRUCTIONS FOR ADDRESSING ARTIFACT.

    Description of Event or Problem · 1

    PT DEATH OCCURRED DURING DEPLOYMENT OF AED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3840A-ABA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death