BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, UKENG

    MDR report key: 4637594 · Received March 25, 2015

    Report

    Report Number
    3030677-2015-00770
    Event Type
    Death
    Date Received
    March 25, 2015
    Report Date
    March 18, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION PENDING. A 510(K): K111693.

    Description of Event or Problem · 1

    THE USER IS QUESTIONING THE FUNCTIONALITY OF THE DEVICE DURING A PATIENT USE EVENT WHERE THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199849 HEARTSTART FR3 ECG, BASIC BUNDLE, UKENG AED MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death