SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM
Received May 13, 2018 · Event occurred May 1, 2018
Report 1643264-2018-00364 · MDR key 7509691
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Smith & Nephew, Inc.Catalog number
72204668S
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
FOREIGN ZIP CODE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT CRASHED HALFWAY THROUGH THE SURGERY, THE CUSTOMER COULD NOT GET THIS UP AND RUNNING AGAIN UNTIL IT LEFT THEATRE. THERE WAS NO BACKUP DEVICE AVAILABLE.
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 HDD CRASHING WAS CONFIRMED. UNIT DID FAIL DURING BOOT UP WITH ERROR MESSAGE STATING THAT UNIT WAS SHUT DOWN ILLEGALLY. THE ERROR COULD BE CAUSED IF THE SYSTEM STOPPED RESPONDING, CRASHED, OR LOST POWER UNEXPECTEDLY. THE COMPLAINT INVESTIGATION HAS CONCLUDED THE CAUSE OF THE FAILURE TO BE A SOFTWARE ERROR AND HDD NEEDS TO BE RECLONED. 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.