BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX

    MDR report key: 1743218 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00163
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    March 12, 2008
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ASSOCIATION 510(K) TRAINING PRODUCT. METHOD: BASED ON CUSTOMER'S ACCOUNT OF THE EVENT. RESULT: A TRAINING PRODUCT WAS USED ON A PT. CONCLUSION: UPON ARRIVAL OF THE PARAMEDICS, AN AED WAS APPLIED; HOWEVER, THE SUBJECT WAS NOT RESUSCITATED. TRAINING PRODUCTS CONTAIN LABELING AND VOICE PROMPTS THAT INFORM THE USER THAT THEY ARE TRAINING PRODUCTS. INSTEAD OF ACTUAL AEDS.

    Description of Event or Problem · 1

    THE USER ATTEMPTED TO DEPLOY TRAINING PRODUCT IN RESPONSE TO POSSIBLE SCA. THE 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 989803138201

    Patients

    Seq Age Sex Outcome Treatment
    1 Death