BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR2

    MDR report key: 1881262 · Received October 6, 2010

    Report

    Report Number
    3030677-2010-00332
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    FCA 10-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) IS THE INITIAL FR2 CLEARANCE. METHOD: DEVICE INTERNAL MEMORY WAS REVIEWED.

    Description of Event or Problem · 1

    THIS AED IS PART OF A RECALL POPULATION FOR (B)(4), UPON THE COMPLETION OF THE INVESTIGATION, IT WAS FOUND TO HAVE A FAULTY COMPONENT ASSOCIATED WITH THE RECALL. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3861A-ABJ

    Patients

    Seq Age Sex Outcome Treatment
    1