BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2090511 · Received April 19, 2011

    Report

    Report Number
    1218950-2011-01083
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILED THE PADDLES PATIENT CONTACT INDICATOR (PCI) TEST. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE LOCAL PHILIP'S REPRESENTATIVE EVALUATED THE DEVICE AND RESOLVED THIS FAILURE BY REPLACING THE PADDLE SET AND PADDLE POCKET CLIPS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED THE PADDLES PATIENT CONTACT INDICATOR (PCI) TEST. THERE WAS NO REPORT OF PATIENT 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