BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORERUNNER

    MDR report key: 1743425 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00204
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    December 23, 2009
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    955628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: ARTIFACT WAS PRESENT AFTER A "SHOCK ADVISED" PROMPT. FURTHER ANALYSIS CAUSED THE DEVICE TO CHANGE SHOCK DECISION TO NO "SHOCK ADVISED". DEVICE LABELING, (INSTRUCTIONS FOR USE AND VOICE PROMPTS) PROVIDE METHODS FOR RESOLVING THIS ISSUE.

    Description of Event or Problem · 1

    ARTIFACT WAS PRESENT DURING ANALYSIS, SUBJECT WAS NOT RESUSCITATED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORERUNNER AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM E01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death