BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 TEXT, BASIC BUNDLE, EUR

    MDR report key: 3871324 · Received April 15, 2014

    Report

    Report Number
    3030677-2014-01072
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT EVAL PENDING. ISSUE IS BEING REPORTED DUE TO PT INVOLVEMENT.

    Description of Event or Problem · 1

    THE USER IS QUESTIONING THE PRESENCE OF AN ARTIFACT DETECTED BY THE DEVICE DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230478 HEARTSTART FR3 TEXT, BASIC BUNDLE, EUR MKJ PHILIPS MEDICAL SYSTEMS 861388 C

    Patients

    Seq Age Sex Outcome Treatment
    1