BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART HOME

    MDR report key: 9355928 · Received November 21, 2019

    Report

    Report Number
    3030677-2019-02324
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Report Date
    November 19, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    K040904
    Removal / Correction Number
    Z-0642-2013, Z-0643-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTING THE BECOME AWARE DATE ONLY TO NOVEMBER 19 2019 FROM JANUARY 19 2019.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154414 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1