BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, USENG

    MDR report key: 2980132 · Received February 21, 2013

    Report

    Report Number
    3030677-2013-00296
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 12, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ISSUE REPORTED BASED ON ASSOCIATED DEPLOYMENT OF DEVICE. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    DEVICE WAS DEPLOYED AND BASED ON ECG ASSESSMENT, ADVISED "NO SHOCK". PT SURVIVED. CUSTOMER HAS REPORTED DIFFICULTY RETRIEVING EVENT DATA FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75232 HEARTSTART FR3 ECG, BASIC BUNDLE, USENG MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1