BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3, REFURB TEXT AED, LANGUAGE CONFIGURATION

    MDR report key: 4648810 · Received March 30, 2015

    Report

    Report Number
    3030677-2015-00811
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Report Date
    March 27, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INVESTIGATION IS PENDING. 510(K): K111693.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, THE USER IS QUESTIONING THE "ANALYSIS ABORTED" NOTIFICATION GIVEN BY THE DEVICE. PATIENT OUTCOME IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208779 FR3, REFURB TEXT AED, LANGUAGE CONFIGURATION AED MKJ PHILIPS MEDICAL SYSTEMS 861388

    Patients

    Seq Age Sex Outcome Treatment
    1