KDS COMPUTED RADIOGRAPHY SYSTEM 400
Received Jun 27, 1997 · Event occurred Jun 1, 1997
Report 1643366-1997-00001 · MDR key 101866
Device
Generic name
Computed Radiography
Manufacturer
Kodak Health Imaging Div.Model number
CR MODEL 400Catalog number
8989774
Lot number
03669150, 3619138 K'S
Patient
63 YR
Narrative
Description of Event or Problem
IMAGE TRANSFER FROM THE KODAK EKTASCAN STORAGE PHOSPOR READER (KESPER) TO THE QUALITY CONTROL WORKSTATION (QCW) WAS NOT POSSIBLE DUE TO POTENTIAL DATABASE CORRUPTION INITIATED BY IMPROPER SHUTDOWN OF BOTH SYSTEMS BY HOSPITAL PERSONNEL. THE CR-400 SYSTEM (COMPUTED RADIOGRAPHY) MET ITS PERFORMANCE SPECIFICATIONS IN ACCORDANCE WITH ITS LABELING. THE MALFUNCTION WAS ATTRIBUTED TO USER ERROR. THE SYSTEMS WERE REBOOTED WITHOUT FOLLOWING THE APPROPRIATE RECOVERY INSTRUCTIONS. THE PT EXPIRED PRIOR TO THE SCANNING AND TRANSFER OF THE IMAGE ACCORDING TO HOSPITAL PERSONNEL.
Remedial action
- Other