BEUDAMED
    FDA Adverse Event Death Summary report: N

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    MDR report key: 1743451 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00176
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    June 26, 2008
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    040904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON CUSTOMER ACCOUNT OF THE EVENT. RESULT: NO CONCLUSION CAN BE DERIVED BECAUSE OF LACK OF CUSTOMER RESPONSE TO RETURN THE DEVICE AND OTHER RELEVANT INFO.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M5068A-ABA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death