BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART HOME

    MDR report key: 7898172 · Received September 21, 2018

    Report

    Report Number
    3030677-2018-02101
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Report Date
    September 17, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    K040904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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
    740281 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1