BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART HOME

    MDR report key: 6146519 · Received December 5, 2016

    Report

    Report Number
    3030677-2016-02897
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 30, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    K040904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS THE SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797163 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1