BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 3170931 · Received June 6, 2013

    Report

    Report Number
    1218950-2013-02188
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING AN OP CHECK A BATTERY FAILURE WAS FOUND. THERE WAS NO CUSTOMER INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251874 HEARTSTART 4000 MKJ PHILIPS MEDICAL SYSTEMS M5500B

    Patients

    Seq Age Sex Outcome Treatment
    1