BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR2

    MDR report key: 1856839 · Received September 16, 2010

    Report

    Report Number
    3030677-2010-00318
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Report Date
    September 16, 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

    BASED ON REVIEW OF THE FILE CONTENT, THE AWARENESS DATE FOR THIS INCIDENT IS (B)(6) 2010. 510(K) IS FOR THE FIRST FR2 CLEARANCE. METHOD: DEVICE INTERNAL MEMORY WAS REVIEWED. NOTE: SUBMISSION OF THIS REPORT DOES NOT IN ITSELF REPRESENT A CONCLUSION BY THE MFR THAT THE CONTENT OF THIS REPORT IS ACCURATE, THAT THE DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON.

    Description of Event or Problem · 1

    PRODUCT SERIAL NUMBER IS WITHIN THE SERIAL NUMBER RANGE FOR (B)(4). DURING THE SUBSEQUENT INTERNAL EVAL OF THE PRODUCT, IT WAS FOUND TO HAVE A FAILED COMPONENT RELATED TO THE FIELD CORRECTIVE ACTION. 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