BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 4821710 · Received June 5, 2015

    Report

    Report Number
    3030677-2015-01370
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 27, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE OF DEVICE TO SELF-TEST.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THIS DEVICE IS FAILING ITS SELF TESTS. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365663 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1