BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS EPIC

    MDR report key: 2507777 · Received March 23, 2012

    Report

    Report Number
    1525965-2012-00010
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Report Date
    February 24, 2012
    Manufacturer
    PHILIPS HEALTHCARE (CLEVELAND)
    Product Code
    KPS
    PMA / PMN Number
    K913471
    Removal / Correction Number
    2916556-07/08/05-026C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED ISSUE HAS BEEN PREVIOUSLY INVESTIGATED WITH RESULTS OF THE INVESTIGATION DETERMINED AND CORRECTIVE ACTION IMPLEMENTED. THE PROBABLE ROOT CAUSE OF CRACKS IS DUE TO POOR WELD QUALITY ON THE ARGUS FORK ARM. PAST STUDIES WERE CONDUCTED ON THE FORK AND ITS DESIGN. ENGINEERING CALCULATIONS OF LOAD FACTORS ON THE IDENTIFIED WELDMENT PARTS WERE PERFORMED AND RESULTS ARE IN COMPLIANCE WITH (B)(4), SUB-CLAUSE 28.4., STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR SAFETY. THIS TESTING ALSO SHOWS THE FAILURE OCCURS IN A SLOW SAFE MANNER. THE FORK WILL DEFLECT TO THE POINT THAT THE SYSTEM CANNOT BE USED BEFORE A COMPLETE SEPARATION WILL OCCUR. ADDITIONALLY THIS SYSTEM HAS BEEN RELEASED FOR APPROX 15 YEARS WITH NO REPORTS OF DEATH OR SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER WAS ON SITE AT THE FACILITY AND IDENTIFIED THREE CRACKS ON THE DETECTOR'S FORK. THE SYSTEM WAS NOT IN USE AT THE TIME OF THE SITE VISIT AND THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGUS EPIC EMISSION COMPUTED TOMOGRAPHY SYSTEM KPS PHILIPS HEALTHCARE (CLEVELAND) 2145-3007A

    Patients

    Seq Age Sex Outcome Treatment
    1