FDA Adverse Event Malfunction Summary report: N

AXIOM ICONUS R200

MDR report key: 778780 · Received November 2, 2006

Report

Report Number
778780
Event Type
Malfunction
Date Received
November 2, 2006
Date of Event
September 11, 2006
Report Date
September 12, 2006
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC
Product Code
KXJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN, US

Narratives

Description of Event or Problem · 1

DURING PARTICULAR PROCEDURES, THE TABLE IS SUPPOSE TO ANGLE VERTICALLY WITH THE PATIENT STRAPPED TO THE TABLE. THE TABLE SHOULD RISE FIRST FROM THE FLOOR AND THEN ANGLE. THE TABLE HAS NOT BEEN RISING PRIOR TO ANGLING. THE TABLE WILL THEREFORE HIT THE FLOOR DURING THE ANGLING PROCESS. AN ERROR MESSAGE "152032" APPEARS ON THE SCREEN WHEN THIS HAPPENS. THIS ERROR MESSAGE HAS ALSO APPEARED WHEN MOVING THE TABLE HORIZONTALLY. THE ERROR MESSAGE CAN SOMETIMES BE OVERRIDDEN. AT OTHER TIMES, THE TABLE BECOMES INOPERABLE AS IF IT LOCKS UP UNTIL THE MANUFACTURER CAN COME AND RESOLVE THE ERROR MESSAGE. THIS DEVICE HAS BEEN IN OUR FACILITY FOR SIX WEEKS. ON ONE OCCASION, WHILE DOING A FLAT AND UPRIGHT ABDOMEN, THE TABLE TOUCHED THE FLOOR. THE PATIENT WAS MOVED TO ANOTHER ROOM AND THERE WAS NO HARM TO THE PATIENT. ON ANOTHER OCCASION, WHEN NO PATIENT WAS ON THE TABLE, THE SAME THING HAPPENED AND THE TABLE LOCKED UP. THERE IS A POTENTIAL FOR PATIENTS TO BE HARMED WHILE GETTING OFF THE TABLE IN THIS VERTICAL POSITION. SIEMENS BROUGHT IN THEIR FIELD ENGINEER, WHO IN TURN BROUGHT IN AN ENGINEER. A TABLE LIFT MODULE WAS REPLACED AND THE SOFTWARE WAS UPDATED. WE HAVE HAD NO MORE INCIDENTS WITH THE TABLE SINCE THE REPAIRS WERE MADE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AXIOM ICONUS R200 X-RAY SYSTEM, RAD/FLUORO KXJ SIEMENS MEDICAL SOLUTIONS USA, INC R200 *

Patients

Seq Age Sex Outcome Treatment
1 *