BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1743398 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00167
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    July 4, 2008
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: THE SUBJECT WAS IN A SHOCKABLE VT RHYTHM, SHOCKS WERE ADVISED, HOWEVER, NO SHOCKS WERE DELIVERED.

    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 M3840A-ABU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death