BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA

    MDR report key: 2080126 · Received April 7, 2011

    Report

    Report Number
    3003768277-2011-00329
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER REPLACED THE HIGH TENSION TANK. THIS SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIGH TENSION (HT) TANK NECESSARY FOR THE GENERATION OF IMAGES USING X-RAY BECAME DEFECTIVE AND NEEDED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA IZL PHILIPS HEALTHCARE 718022

    Patients

    Seq Age Sex Outcome Treatment
    1