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MalfunctionIXK

FUJI COMPUTED RADIOGRAPHY FCR 9000 SYSTEM

Received Mar 25, 1998 · Event occurred Feb 25, 1998

Report 2443168-1998-00001 · MDR key 159942

Device

Generic name

Computed Radiography System

Model number

CRIR317

Catalog number

XIR9000I

Lot number

*

Patient

*

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN IMAGE FOR ONE PT WAS ASSOCIATED WITH THE IDENTIFICATION INFO OF ANOTHER PT.

Additional Manufacturer Narrative

REPRESENTATIVES FROM SERVICE AND TECHNICAL SUPPORT DEPTS EVALUATED THE DEVICE IN QUESTION AND FOUND NO DEFECTS OR DISCREPANCIES. THE SERVICE AND TECHNICAL SUPPORT DEPTS COULD NOT FIND THE EXACT CAUSE OF THIS CONDITION. HOWEVER, THE REPORTED CONDITION CAN BE DUPLICATED IF: 1) THE OPERATOR DOES NOT CLEAR THE PREVIOUS PT IDENTIFICATION INFO AFTER REBOOTING THE DEVICE. OR 2) THE CLOCKS IN THE ID TERMINALS DISAGREE. OR 3) THE ID FOR A NEWLY COMPOSED IMAGING PLATE REMAINS UNPROCESSED FOR SOME REASON WHEN IT IS READ WITHOUT DELIBERATELY ACCOMPLISHING ID REGISTRATION, THE SYSTEM WILL PROCESS THE IMAGING PLATE ON THE BASIS OF THE ID INFO, JUDGING THAT ID REGISTRATION HAS BEEN COMPLETED. CO REVIEWED THE RECORDS AND FOUND THIS TO BE AN ISOLATED INCIDENT. ALTHOUGH CO HAS NO OTHER REPORTS OF THIS NATURE, TO REDUCE THE POTENTIAL FOR THIS TYPE OF EVENT, CO CREATED AND HAS IMPLEMENTED SOFTWARE UPGRADE VERSION IDT718/719 VERSION 10. BASED ON THE ABOVE INFO CO'S INVESTIGATION HAS BEEN CONCLUDED.