BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FR2+

    MDR report key: 1651570 · Received April 2, 2010

    Report

    Report Number
    3030677-2010-00056
    Event Type
    Death
    Date Received
    April 2, 2010
    Report Date
    April 2, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    06365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE MEMORY AND ECG REVIEWED - AED NOT RETURNED. DEVICE INTERNAL MEMORY REVIEWED. CUSTOMER ORIGINALLY REPORTED THAT AED FAILED TO SHOCK VT RHYTHM. SUBSEQUENT REVIEW OF ECG CONCLUDES THAT ARTIFACT RESULTING FROM CPR WAS MISTAKENLY IDENTIFIED BY THE CUSTOMER AS VT IN INITIAL COMMUNICATION OF EVENT. PRESENTING RHYTHM WAS ASYSTOLE REPORT IS BEING FILED AS IT CANNOT BE CONCLUDED THAT DEVICE DID NOT CONTRIBUTE TO EVENT. ANALYSIS OF EVENT DATA INDICATES THAT AED COULD NOT ANALYZE DUE TO EXTERNAL ARTIFACT. DEVICE LABELING AND VOICE PROMPTS PROVIDE CAUTIONS AND INSTRUCTIONS REGARDING STEPS TO AVOID THIS ISSUE.

    Description of Event or Problem · 1

    PT DEATH REPORTED DURING DEPLOYMENT OF AED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FR2+ AED MKJ PHILIPS MEDICAL SYSTEMS 3860A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death