BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 1575677 · Received December 22, 2009

    Report

    Report Number
    3030677-2009-00083
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    January 30, 2008
    Report Date
    December 22, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INTERNAL MEMORY REVIEWED. CONCLUSION: THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUSIVELY STATED THAT RECURRENCE WOULD NOT LEAD TO A DELAY IN THERAPY.

    Description of Event or Problem · 1

    OOB SELF TEST FAILURE - SHOCK BUTTON FUNCTION COULD NOT BE VERIFIED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS 989803146771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other