BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB TARGET POSITIONER

    MDR report key: 872401 · Received March 13, 2007

    Report

    Report Number
    9617016-2007-00015
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    February 26, 2007
    Report Date
    March 13, 2007
    Manufacturer
    BRAINLAB
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR EQUIPMENT DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. THE INVESTIGATION SHOWED OUR PRODUCT WAS WORKING WITHIN SPECIFICATIONS AND 3RD PARTY PRODUCTS WERE INVOLVED. 3RD PARTY VENDORS HAVE BEEN CONTACTED AND ARE INITIATING INVESTIGATION.

    Description of Event or Problem · 1

    WE HAVE BEEN ADVISED THAT ONE OR MORE PTS MAY HAVE BEEN MISTREATED WHEN THE HOSPITAL USED THESE PRODUCTS IN COMBINATION. PRODUCTS IMPLICATED IN THIS REPORT: BRAINLAB TARGET POSITIONER, PHILIPS PINNACLE RADIATION THERAPY PLANNING SYSTEM (AND UNCONFIRMED LEKSELL HEAD RING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB TARGET POSITIONER * MUJ BRAINLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *