BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2013762 · Received February 4, 2011

    Report

    Report Number
    3030677-2011-00009
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    May 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    Z-0470-2011/Z-0473-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE INTERNAL MEMORY WAS REVIEWED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    THE DEVICE IS PART OF THE RECALL POPULATION Z-0470-2011 THROUGH Z-0473-2011. UPON COMPLETION OF THE DEVICE INVESTIGATION, IT WAS FOUND TO HAVE A COMPONENT FAILURE (U8) THAT WAS RELATED TO THE DEVICE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1