BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL LINEAR ACCELERATOR

    MDR report key: 11868 · Received March 8, 1994

    Report

    Report Number
    MW1000975
    Event Type
    Malfunction
    Date Received
    March 8, 1994
    Date of Event
    February 21, 1994
    Report Date
    February 24, 1994
    Manufacturer
    SIEMENS MEDICAL LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE REPORTED UNCOMMANDED JAW MOVEMENT WAS NOTICED DURING A MONTHLY QA TEST ON THE LINEAR ACCELERATOR SYSTEM ON 2/21/94. THERE HAD BEEN A PREVIOUS OBSERVATION OF UNCOMMANDED JAW MOVEMENT DURING A PT SETUP ON 2/15/94, BUT THE PROBLEM COULD NOT BE DUPLICATED WHEN SVC PERSONNEL ARRIVED. AS THE REPORTED SYMPTOM WAS EXTREMELY INTERMITTENT, AGAIN EFFORTS TO TROUBLESHOOT THE PROBLEM WERE INITIALLY UNSUCCESSFUL. ON 3/4/94 AND AGAIN ON 5/17/94 THE SYMPTOM WAS OBSERVED DURING PT SETUP. SIEMENS MEDICAL SYSTEMS INC. FILED MEDICAL DEVICE REPORTS ON EACH OF THESE REPORTED EVENTS. AT THIS TIME, FDA ACKNOWLEDGMENTS OF THESE MDRS ARE PENDING. REMEDIAL ACTION IN THIS CASE IS LIMITED TO REPAIR OF THE UNIT WHICH EXPERIENCED THE EVENT. SEARCHING THE COMPLAINT FILES FOR SIMILAR EVENTS YIELDED NEGATIVE RESULTS, INDICATING THAT THIS WAS AN ISOLATED EVENT, EXPERIENCED BY ONE SYSTEM ONLY. A ROUTINE HAZARD ANALYSIS WAS PERFORMED AS REQUIRED BY THE PROCEDURE. THE RESULT OF THE HAZARD ANALYSIS INDICATED A LOW PROBABILITY OF OCCURRENCE AND LOW SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL LINEAR ACCELERATOR IYE SIEMENS MEDICAL LABORATORIES KD

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other