IMAGE MANAGEMENT SYSTEM 660HD-E
Received Apr 6, 2017 · Event occurred Mar 16, 2017
Report 1643264-2017-00190 · MDR key 6464992
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Smith & Nephew, Inc.Catalog number
72204668
Product problems
- 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)(4).
Description of Event or Problem
IT WAS REPORTED THE SCREEN WENT BLACK ON THE IMAGE MANAGEMENT SYSTEM 660HD-E. THIS OCCURRED DURING THE PROCEDURE. A BACKUP DEVICE WAS READILY AVAILABLE. THERE WERE NO DELAYS OR PATIENT INJURIES REPORTED.
Additional Manufacturer Narrative
DEVICE INVESTIGATION NARRATIVE - COMPLAINT OF BLANK SCREEN COULD NOT BE REPRODUCED. UNIT PASSED FUNCTIONAL TESTING DURING 6 HOUR BURN-IN INCLUDING TOUCHSCREEN FUNCTIONS AND CAPTURING VIDEO STILLS AND CLIPS. DISPLAY REMAINED CONSTANT THROUGHOUT FUNCTIONAL TESTING AND BURN-IN. ALL VIDEO INPUTS/OUTPUTS NORMAL AND UNIT'S SOFTWARE PERFORMED AS EXPECTED. UNIT WAS TESTED IN BOTH PAL AND NTSC FORMATS AND BOTH ANALOG AND DIGITAL VIDEO OUTPUTS. NO PROBLEM FOUND. A REVIEW OF THE DEVICE HISTORY RECORD FOR SERIAL NUMBER (B)(4) SHOWS THAT THIS UNIT PASSED ALL ACCEPTANCE CRITERIA AND WAS COMPLIANT UPON RELEASE FOR DISTRIBUTION ON FEBRUARY OF 2017. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.