BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART FR2+

    MDR report key: 1574952 · Received January 8, 2010

    Report

    Report Number
    3030677-2010-00004
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    November 24, 2009
    Report Date
    January 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    06365
    Removal / Correction Number
    Z-00063-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RETURNED TO MFG SITE. REPORT FILED BECAUSE IT CANNOT BE CONCLUSIVELY STATED THAT REOCCURRENCE WOULD NOT LEAD TO DELAY OF THERAPY.

    Description of Event or Problem · 1

    PRODUCT ISSUED SELF TEST WARNING CONSISTENT WITH ISSUES BEING ADDRESSED BY Z-00063-2010. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FR2+ AED MKJ PHILIPS MEDICAL SYSTEMS 3863A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other