BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR2

    MDR report key: 1773282 · Received July 13, 2010

    Report

    Report Number
    3030677-2010-00094
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT PENDING. CLASSIFICATION & ASSIGNMENT OF Z # PENDING. PHILIPS INTERNAL REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    PRODUCT BEING RETURNED FOR SYMPTOMS ASSOCIATED WITH CURRENT FIELD ACTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M3860A-ABJ

    Patients

    Seq Age Sex Outcome Treatment
    1