BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2933137 · Received January 21, 2013

    Report

    Report Number
    3030677-2013-00090
    Event Type
    Death
    Date Received
    January 21, 2013
    Date of Event
    November 9, 2012
    Report Date
    January 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INVESTIGATION PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AED WAS DEPLOYED FOR A RESUSCITATION ATTEMPT - SUBJECT WAS NOT RESUSCITATED. DATE OF DEPLOYMENT: (B)(6) 2012. DATE OF REPORT TO PHILIPS: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28734 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death