BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1882438 · Received October 20, 2010

    Report

    Report Number
    1218950-2010-01989
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Report Date
    September 20, 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). THE CUSTOMER REPORTED THAT THE PADDLE SET ELECTRODES WERE FAULTY. THE CUSTOMER DID NOT INDICATE THE FAILURE MODE. THERE WAS NO REPORT OF PT INVOLVEMENT OR IMPACT. THE CUSTOMER ORDERED A REPLACEMENT PADDLE SET TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADDLE SET ELECTRODES WERE FAULTY. THE CUSTOMER DID NOT INDICATE THE FAILURE MODE. THERE WAS NO REPORT OF PT INVOLVEMENT OR IMPACT.

    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