BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE VERSION 9.0

    MDR report key: 2006276 · Received February 25, 2011

    Report

    Report Number
    MW5019591
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOFTWARE REPORTED TREATMENT COORDINATES IN UNITS OF CM, BUT HARDWARE IS BUILT AND MARKED IN UNITS OF MM. THE PT WAS SET UP WITH INCORRECT TREATMENT COORDINATES. THE ERROR WAS FOUND VIA IMAGING BEFORE RADIATION DOSE WAS DELIVERED. THE SOFTWARE HAS BEEN CHANGED AS OF VERSION 9.0 TO REPORT COORDINATES IN UNITS OF CM. THIS IS INCORRECT AND DANGEROUS BECAUSE THE HARDWARE MODELED IS BUILT IN UNITS OF MM. THE VENDOR FAILED TO ADHERE TO (B)(6) REQUIREMENTS, SPECIFICALLY: PHILIPS MEDICAL SYSTEMS FAILED TO PROVIDE THE RESULTS OF THE (B)(6) TYPE TEST TO THE HOSPITAL AT THE TIME OF SOFTWARE INSTALLATION. NO TEST PROCEDURE WAS PROVIDED BY PHILIPS MEDICAL SYSTEMS TO THE HOSPITAL AS REQUIRED BY (B)(4). IN FACT, NO ACCEPTANCE TESTING PROCEDURE WAS PROVIDED AT ALL BY PHILIPS MEDICAL SYSTEMS AS EVIDENCED BY THE FACT THAT NO DOCUMENT EXISTS WITH SIGNATURES OF EITHER A PHILIPS MEDICAL SYSTEMS REP OR A REP OF THE HOSPITAL. INDEED, SUCH A DOCUMENT WOULD BE IMPOSSIBLE TO OBTAIN SINCE NO REP FROM PHILIPS MEDICAL SYSTEMS WAS ON SITE DURING THE SOFTWARE UPGRADE -ALL WORK WAS DONE REMOTELY VIA THE INTERNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE VERSION 9.0 NONE MUJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening BRW STEREOTACTIC HEAD FRAME