IMAGE MANAGEMENT SYSTEM 660HD-E
Received May 28, 2018 · Event occurred May 18, 2018
Report 1643264-2018-00413 · MDR key 7547840
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Smith & Nephew, Inc.Catalog number
72204668
Product problems
- Application Interface Becomes Non-Functional Or Program Exits Abnormally
- Loss of Power
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED.A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT WHEN TAKING THE PICTURE THE SCREEN FROZE AND THE SYSTEM SHUT DOWN RESULTING IN THE LOSS OF PICTURE. OCCURRED DURING PROCEDURE. A BACK-UP WAS AVAILABLE, NO DELAY REPORTED.
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 EXTERIOR OF PRODUCT AND NO DAMAGE WAS OBSERVED. COMPLAINT OF FROZEN SCREEN AND SHUTTING DOWN WAS CONFIRMED. THE SCREEN FROZE WHILE TRYING TO CAPTURE A PICTURE AND THEN REPEATEDLY TRIED TO REBOOT. UNIT THEN FAILED BOOT UP WITH RUNTIME ERROR MESSAGE. THE COMPLAINT INVESTIGATION HAS CONCLUDED THE CAUSE OF THE FAILURE TO BE A SOFTWARE ERROR AND HDD NEEDS TO BE RECLONED. FACTORS WHICH CAN CONTRIBUTE TO BOOT UP FAILURE INCLUDE AN ILLEGAL SHUT DOWN OR LOSS OF POWER UNEXPECTEDLY. 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.