BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2123542 · Received June 9, 2011

    Report

    Report Number
    1218950-2011-01655
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    May 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN ISSUE WITH THE EXTERNAL PADDLES. THE SPECIFIC ISSUE WITH THE PADDLE SET WAS NOT REPORTED AND COULD NOT BE CONFIRMED. THERE WAS NO REPORT OF PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THE EXTERNAL PADDLES. THE SPECIFIC ISSUE WITH THE PADDLE SET WAS NOT REPORTED AND COULD NOT BE CONFIRMED. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1