BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX

    MDR report key: 1801382 · Received August 12, 2010

    Report

    Report Number
    3030677-2010-00307
    Event Type
    Death
    Date Received
    August 12, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 12, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    05004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORT THAT AED INDICATED LOW BATTERY DURING DEPLOYMENT. SECOND AED DEPLOYED. SUBJECT WAS NOT RESUSCITATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRX AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM 989803138271

    Patients

    Seq Age Sex Outcome Treatment
    1 Death