BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASYS ULTRA

    MDR report key: 3147328 · Received May 31, 2013

    Report

    Report Number
    1525965-2013-00148
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    September 10, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K993946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE IT DEPARTMENT AT THE CUSTOMER SITE RAN A NESSUS SCAN ON THE PEGASYS PROCESSING STATION. IT WAS DETERMINED THAT THE PEGASYS SYSTEM WAS VULNERABLE FOR THE FOLLOWING: TOOLTALK SERVICE, RSH ON FINGER OUTPUT, USER MOUNTABLE NFS SHARES, AND MAIL RELAYING. THE PROBABLE ROOT CAUSE IS THE INHERENT VULNERABILITIES IN THE SEND MAIL DAEMON (PROCESS) THAT CAN BE EXPLOITED TO ALLOW AN UNAUTHORIZED PERSON TO GAIN ROOT (SUPERUSER) ACCESS. THE DAEMON IS PART OF THE OPERATING SYSTEM SOFTWARE PROVIDED BY SUN. THIS DAEMON CAN BE DISABLED WITH NO ADVERSE EFFECTS TO THE WAY THE PEGASYS CLUSTER OPERATES. THIS EVENT IS A NETWORK SECURITY SCAN ISSUE THAT DOES NOT ADVERSELY EFFECT THE OPERATION OF THE PEGASYS. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT THE SITE IT DEPARTMENT RAN A NESSUS SCAN ON THE PEGASYS PROCESSING STATION. ONCE THE NESSUS SCAN WAS COMPLETED, IT FOUND THAT THE PEGASYS WAS VULNERABLE FOR THE FOLLOWING: TOOLTALK SERVICE, RSH ON FINGER OUTPUT, USER MOUNTABLE NFS SHARES, AND MAIL RELAYING. THERE WAS NO REPORT OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240533 PEGASYS ULTRA KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2167-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1