BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR2

    MDR report key: 1791240 · Received August 6, 2010

    Report

    Report Number
    3030677-2010-00267
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    Z-00063-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD ¿ DEVICE INTERNAL MEMORY REVIEWED.

    Description of Event or Problem · 1

    DEVICE DISPLAYED AN ERROR CODE THAT WAS SUBJECT TO SUBSEQUENT FIELD ACTION (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1