RFB 660 HD-E IMAGE MANAGEMENT SYSTEM
Received Apr 3, 2019 · Event occurred Mar 21, 2019
Report 1643264-2019-00243 · MDR key 8478094
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Smith & Nephew, Inc.Catalog number
72204668F
Product problems
- No Display/Image
- Application Program Freezes or Fails to Launch
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 THE DEVICE IS FOUND UNSATISFACTORY DUE LOSS OF HDSDI VIDEO SIGNAL. A FINE VERTICAL LINE COVERING THE WHOLE ENTIRE DISPLAY SCREEN AFTER AROUND 10-15 MINUTES OF STILL AND VIDEO CAPTURING., DISABLING THE APPLICATION SCREEN. THERE WAS A COMPLETELY LOSS OF IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES 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 PRODUCT AND NO ISSUE WAS OBSERVED. COMPLAINT OF HD-SDI OUTPUT MALFUNCTION WAS CONFIRMED. THE UNIT FAILED BOOT UP WITH A VIDEO CARD FAILURE. THE HD-SDI LIVE VIDEO OUTPUT IS BLANK. CAUSE OF HD-SDI OUTPUT MALFUNCTION IS A DEFECTIVE VIDEO CAPTURE CARD. UNIT PASSED FUNCTIONAL TESTING AND ALL VIDEO INPUTS AND OUTPUTS NORMAL WITH A KNOWN GOOD CAPTURE CARD INSTALLED. THE COMPLAINT INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE HD-SDI OUTPUT FAILURE WAS CAUSED BY A DEFECTIVE ELECTRONIC COMPONENT ON THE VIDEO CARD. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE WAS FOUND UNSATISFACTORY DUE LOSS OF HDSDI VIDEO SIGNAL. A FINE VERTICAL LINE COVERING THE WHOLE ENTIRE DISPLAY SCREEN AFTER AROUND 10-15 MINUTES OF STILL AND VIDEO CAPTURING., DISABLING THE APPLICATION SCREEN. THERE WAS A COMPLETELY LOSS OF IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES REPORTED.