BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTREAM FR2

    MDR report key: 1574954 · Received January 8, 2010

    Report

    Report Number
    3030677-2010-00007
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    December 19, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    06365
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS FOR INITIAL FR2 CLEARANCE. INTERNAL DEVICE MEMORY REVIEWED. CONCLUSION: INCIDENTS ARE BEING REPORTED AS IT CANNOT BE CONCLUSIVELY STATED THAT RECURRENCE WOULD NOT RESULT IN DELAY OF THERAPY. DEVICE LABELING PROVIDES INFO REGARDING POTENTIAL REASONS FOR PAD CONTACT ISSUES (DRY SKIN, EXCESSIVE BODY HAIR, OILY SKIN, ETC.).

    Description of Event or Problem · 1

    TWO INSTANCES REPORTED BY USER WHERE SAME AED INDICATED MARGINAL PAD CONTACT DURING DEPLOYMENT. SECOND EVENT; 0(B) (6) 2009. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other