BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART FR2

    MDR report key: 1574957 · Received January 8, 2010

    Report

    Report Number
    3030677-2010-00006
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    August 22, 2008
    Report Date
    January 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    03565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL DEVICE MEMORY REVIEWED. CONCLUSION: THIS REPORT IS FILED AS IT CANNOT CONCLUSIVELY BE STATED THAT RECURRENCE WOULD NOT RESULT IN A 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

    AED INDICATED ERRATIC PAD CONTACT DURING DEPLOYMENT. AED DID DELIVER SHOCK. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3040A

    Patients

    Seq Age Sex Outcome Treatment
    1