BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2343174 · Received November 2, 2011

    Report

    Report Number
    3030677-2011-00185
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUDED THAT RECURRENCE WOULD NOT RESULT IN AN ADVERSE EVENT.

    Description of Event or Problem · 1

    RETROSPECTIVE REPORT PER 803.50 (A) (MDR # 3030277-2011-00066). DEVICE DISPLAY MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1