BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2040305 · Received February 15, 2011

    Report

    Report Number
    3030677-2011-00032
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    February 4, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    Z-0470-2011 THROUGH Z-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY PENDING DEVICE EVAL.

    Description of Event or Problem · 1

    AED IS PART OF A RECALLED POPULATION FOR FCA 10-02 AND WAS FOUND TO BE FAILING SELF TEST. PENDING DEVICE EVAL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MKJ PHILIPS MEDICAL SYSTEMS (HTST)

    Patients

    Seq Age Sex Outcome Treatment
    1