BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 275713 · Received April 7, 2000

    Report

    Report Number
    MW4002749
    Event Type
    Malfunction
    Date Received
    April 7, 2000
    Date of Event
    March 21, 2000
    Report Date
    March 22, 2000
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    ITY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PROCEDURE WAS BEING PERFORMED, FOR A PT, WHEN THE POWER TO THE X-RAY EQUIPMENT FAILED. THE TABLE DRIFTED BACK TO ABOUT A 20-30% ANGLE AND STOPPED. THE TOWER BEGAN DRIFTING DOWNWARD, WHICH REQUIRED THAT THE ATTENDING RADIOLOGIST TO MANUALLY SUPPORT THE WEIGHT OF THE TOWER TO KEEP THE TOWER FROM LOWERING ONTO THE PT. ALL EQUIPMENT CONTROLS WERE UNRESPONSIVE. THE PT WAS MOVED FROM THE X-RAY TABLE. NO INJURIES WERE REPORTED, TO THE PT OR STAFF. RPTR TALKED WITH THE TECH AND LEARNED THAT THE MALFUNCTION ACTUALLY COULD HAVE CREATED AN INJURY HAD THE RADIOLOGIST NOT SUPPORTED THE WEIGHT OF THE TOWER UNTIL THE PT WAS MOVED FROM THE X-RAY TABLE. WHEN THE REPAIR TECH ARRIVED, RPTR SPOKE EXTENSIVELY WITH THEM IN AN ATTEMPT TO LEARN ABOUT THE MECHANISM THAT CONTROLS THE TOWER. FROM THE CONVERSATION, IT APPEARS THAT THE FAIL-SAFE MECHANISM DID NOT FUNCTION PROPERLY. ALSO, IF THE TABLE WAS IN THE FLAT POSITION, THE TOWER COULD DROP TO ABOUT SIX INCHES ABOVE THE TABLE, WHICH WOULD PLACE THE TOWER ONTO A PT. THE REPAIR TECH DID MENTION THAT THIS PARTICULAR PROBLEM, REFERRED ABOVE, SHOULD NOT HAVE OCCURRED BASED UPON SAFEGUARDS INCORPORATED INTO THE EQUIPMENT. THE EQUIPMENT WAS REPAIRED AND PLACED BACK INTO SVC. RPTR QUESTIONS: WHY THE FAIL-SAFE MECHANISM DID NOT FUNCTION PROPERLY AND COULD THIS PARTICULAR PROBLEM OCCUR IN THE FUTURE. CORRECTIVE ACTION: TROUBLESHOT SPIDER GEAR, TABLE TILT AXIS UNDEMANDED MOVEMENT, K2 RELAY INACTIVE DUE TO SAFE CIRCUIT ORDERED PCB CONTROL. RECALIBRATE TABLE TILT REFERENCE. REPLACED TABLE CONTROL PCB. CALIBRATE AND TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI X-RAY TUBE ITY PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 9806-300-71202 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO