BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1743461 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00168
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    April 14, 2008
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    K003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: INTERNAL DEVICE MEMORY AND ECG RELATED TO INCIDENT REVIEWED. RESULT: ARTIFACT PRESENT DURING ANALYSIS. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM (ASYSTOLE), NO SHOCK WAS ADVISED AND NO SHOCK WAS DELIVERED. DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME. DEVICE LABELING, (INSTRUCTIONS FOR USE AND VOICE PROMPTS) PROVIDE METHODS FOR RESOLVING THIS ISSUE.

    Description of Event or Problem · 1

    SUBJECT WAS NOT RESUSCITATED. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death