BEUDAMED
    FDA Adverse Event Death Summary report: N

    FR2

    MDR report key: 1743455 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00186
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    July 7, 2009
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE INTERNAL MEMORY AND ECG WERE EVALUATED FOR THIS INCIDENT. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM (NO SHOCK WAS ADVISED/NO SHOCK DELIVERED). DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO ECG SIGNAL. CUSTOMER REPLACED PADS AND ECG WAS PRESENT. SUBJECT WAS NOT RESUSCITATED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 PADS MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3841A-ABF

    Patients

    Seq Age Sex Outcome Treatment
    1 Death