BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1743193 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00232
    Event Type
    Death
    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: BASED ON THE CUSTOMER'S ACCOUNT OF THE INCIDENT. RESULT: ARTIFACT PRESENT DURING ANALYSIS. DEVICE LABELING, (INSTRUCTION FOR USE AND VOICE PROMPTS) PROVIDE METHODS FOR RESOLVING ARTIFACTS. 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.

    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-ABU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death