IMAGE MANAGEMENT SYSTEM 660HD-E
Received Aug 20, 2019 · Event occurred Jul 27, 2019
Report 1643264-2019-00551 · MDR key 8913174
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Smith & Nephew, Inc.Catalog number
72204668
Product problems
- No Display/Image
- No Display/Image
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE HAD A BLANK TOUCH SCREEN PANEL WITH FAILED APPLICATION " UNABLE TO OPERATE". NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND NO ISSUE WAS OBSERVED. COMPLAINT OF DISPLAY MALFUNCTION WAS CONFIRMED. DISPLAY BLANKS OUT AFTER THE TITLE PAGE DURING BOOT UP. THE SOFTWARE ON THE HDD DOES NOT FUNCTION AS EXPECTED. THE UNIT PASSED FUNCTIONAL TESTING WITH A KNOWN GOOD HDD INSTALLED. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE HAS BEEN DETERMINED TO BE CORRUPTED SOFTWARE ON THE HDD. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED.