BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1850118 · Received September 21, 2010

    Report

    Report Number
    1218950-2010-01666
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    August 24, 2010
    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). PHILIPS DID NOT EVALUATE THIS DEVICE. THE CUSTOMER DID EVALUATE THE DEVICE, HOWEVER, AND LOCALIZED THE ISSUE TO A FAILED INTERNAL PADDLE SET. A REPLACEMENT PADDLE SET WAS ORDERED. WE ARE CONSIDERING THIS A MALFUNCTION OF THE INTERNAL PADDLE SET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE VIA INTERNAL PADDLES. 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