BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART HOME

    MDR report key: 6097087 · Received November 11, 2016

    Report

    Report Number
    3030677-2016-02694
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    November 7, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE IS POWERING ON BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748388 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A 65768P

    Patients

    Seq Age Sex Outcome Treatment
    1