BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 2431125 · Received December 28, 2011

    Report

    Report Number
    3030677-2011-00348
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL PENDING. INITIAL REPORT IS BEING FILED DUE TO REPORT OF POTENTIAL MALFUNCTION FOR AED WITHIN POPULATION OF Z-1781-2008.

    Description of Event or Problem · 1

    MALFUNCTION REPORTED IN DEVICE SUBJECT TO FIELD CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ONSITE MKJ PHILIPS MEDICAL SYSTEMS (HTST) M5067A

    Patients

    Seq Age Sex Outcome Treatment
    1