BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 6189701 · Received December 20, 2016

    Report

    Report Number
    3030677-2016-03057
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    December 15, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Removal / Correction Number
    Z-0642-2013, Z-0643-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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
    840375 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1