BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XLT

    MDR report key: 3182302 · Received June 10, 2013

    Report

    Report Number
    1218950-2013-02277
    Event Type
    Malfunction
    Date Received
    June 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ENERGY VALUES (JOULES) WERE INCORRECT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261761 HEARTSTREAM XLT MKJ PHILIPS MEDICAL SYSTEMS M3500B

    Patients

    Seq Age Sex Outcome Treatment
    1