THD EVOLUTION US
Received Nov 6, 2014 · Event occurred Oct 2, 2014
Report 3006680097-2014-00005 · MDR key 4281164
Product problems
- Noise, Audible
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE THD EVOLUTION USED DURING THE REPORTED CASES WAS RECEIVED ON 11/05/2014 IN THD (B)(4) FOR TECHNICAL INVESTIGATION. VISUAL INSPECTION, DID NOT IDENTIFY ANY DEFECTS. THE TECHNICAL INVESTIGATION COULD NOT BE COMPLETED WITHIN THE 30-DAY REPORTABILITY TIME FRAME. ADD'L INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.
Description of Event or Problem
THE HOSP CALLED THE THD SPECIALIST ABOUT A VERY SHRILL SOUND THEIR THD EVOLUTION DEVICE WAS MAKING DURING A CASE. DURING THE FOLLOWING SCHEDULED THD CASE, THE THD EVOLUTION MACHINE HAD THE SAME PROBLEM. THEY USED ANOTHER THD EVOLUTION DEVICE AND THE CASE WAS COMPLETED SUCCESSFULLY.
Remedial action
- Notification