BEUDAMED
    FDA Adverse Event Other Summary report: N

    XCELERA

    MDR report key: 1568388 · Received December 10, 2009

    Report

    Report Number
    3003768277-2009-00159
    Event Type
    Other
    Date Received
    December 10, 2009
    Date of Event
    January 4, 2009
    Report Date
    May 6, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LLZ
    PMA / PMN Number
    K022788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE RESPONSIBILITY FOR THE MAINTENANCE OF THE IT EQUIPMENT (WHICH REQUIRES AMONGST OTHERS THE INSTALLATION OF THE MICROSOFT OFFICE SECURITY PATCHES OF VIRUS SCANNERS) LIES WITH THE CUSTOMER. PHILIPS MEDICAL SYSTEMS IS NOT RESPONSIBLE FOR THE INSTALLATION OR MAINTENANCE OF ANTIVIRUS SOFTWARE OR FOR THE INTEGRITY OF THE XCELERA SYSTEM INFECTED WITH A COMPUTER VIRUS. APPROPRIATE NETWORK FIREWALLS AND VIRUS PROTECTION IS NOT THE RESPONSIBILITY OF PHILIPS. ALTHOUGH PHILIPS UNDERSTANDS THE CUSTOMER'S POINT OF VIEW, PHILIPS BELIEVES THAT THE MEDICAL DEVICE WAS NOT A CONTRIBUTOR TO THE WORM ATTACK. THERE WERE NO REPORTED INJURIES. PHILIPS IS ONLY REPORTING THIS MATTER DUE TO THE HOSPITAL'S SAFETY REPORTED CLAIMS.

    Description of Event or Problem · 1

    THE REPORT IS BEING FILED UPON NOTIFICATION FROM OUR INFO TECHNOLOGY MANUFACTURER IN (B)(4) TO SUBMIT THIS EVENT. IN A RETROSPECTIVE REVIEW OF PHILIPS COMPLAINTS/CORRECTIVE ACTIONS, THIS ISSUE IS NOW BEING REPORTED AS A MDR. SEVERAL COMPUTERS IN THE HOSPITAL (B)(6)GOT INFECTED WITH A COMPUTER VIRUS. AS A RESULT OF THIS INFECTION, THE SOFTWARE (XCELERA) COULD NOT BE USED FROM TIME TO TIME. THIS HOSPITAL FELT THAT THIS COULD HAVE CAUSED A DEATH OR SERIOUS HEALTH DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELERA LLZ (SYSTEM, IMAGING PROCESSING, RADIOLOGICAL) LLZ PHILIPS MEDICAL SYSTEMS 830032 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA