BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2381068 · Received November 14, 2011

    Report

    Report Number
    3030677-2011-00281
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Report Date
    April 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 (HTST) M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1