BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEART START ON-SITE

    MDR report key: 1611825 · Received February 19, 2010

    Report

    Report Number
    3030677-2010-00016
    Event Type
    Other
    Date Received
    February 19, 2010
    Report Date
    February 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INTERNAL MEMORY REVIEWED. CONCLUSION: DEVICE LOW BATTERY WARNINGS IGNORED. THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUSIVELY STATED THAT RECURRENCE WOULD NOT LEAD TO ADVERSE EVENT.

    Description of Event or Problem · 1

    CUSTOMER ATTEMPTED TO DEPLOY AED WITH DEPLETED BATTERY. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START ON-SITE AED MKJ PHILIPS MEDICAL SYSTEMS 5066A

    Patients

    Seq Age Sex Outcome Treatment
    1