BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ALLURA INTEGRIS 5000

    MDR report key: 1701408 · Received May 12, 2010

    Report

    Report Number
    1701408
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    November 12, 2008
    Report Date
    May 12, 2010
    Manufacturer
    PHILIP MEDICAL SYSTEMS USA, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN EARLY (B) (6) 2008, A CONTRACTED THIRD PARTY SERVICED THE HOSPITAL'S PHILIPS INTEGRIS 5000 FLUOROSCOPY UNIT IN RESPONSE TO THE ANNUAL REGULATORY RADIATION MACHINE PHYSICIST'S INSPECTION. SEVERAL WEEKS LATER, A PATIENT UNDERWENT CARDIAC ABLATION. THE DOSIMETER REPORT FOR A PHYSICIAN FOR THIS MONITORING PERIOD INDICATED A HIGH READING. THE PHYSICIAN STATED THAT THE BADGE WAS LEFT BY THE SOURCE. ROOM MONITORING BADGES AND OTHER EP STAFF BADGES WERE WITHIN THE NORMAL RANGE. THE SUBSEQUENT DOSIMETER MONITOR REPORT SHOWED ANOTHER HIGH READING (LEVEL II) FOR THE PHYSICIAN. THE THIRD PARTY SERVICER WAS CONTACTED FOR ON-SITE SERVICE OF THE UNIT, AND DISCOVERED THAT AN INTERNAL "LOW DOSE" MODE HAD BEEN LINKED TO THE "HIGH DOSE MODE" DURING A PRIOR SERVICE VISIT IN (B) (6) 2008 (BY A TECHNICIAN WORKING FOR THE THIRD PARTY SERVICING COMPANY). SEVERAL MONTHS AFTER THE PATIENT'S ABLATION PROCEDURE, THE PATIENT'S PHYSICIAN INFORMED THE HOSPITAL'S IMAGING DIRECTOR OF PATIENT RADIATION BURNS AND TREATMENT. HOSPITAL RISK MANAGEMENT INITIATED RECENT ATTEMPT TO CONTACT PATIENT WITH "BROWN PATCH" AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS ALLURA INTEGRIS 5000 X-RAY SYSTEM, CATH/ANGIO JAA PHILIP MEDICAL SYSTEMS USA, INC. INTEGRIS 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R