MalfunctionJAF
THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE
Received Jan 9, 2015 · Event occurred Nov 1, 2014
Report 3006680097-2015-00002 · MDR key 4427223
Product problems
- Failure to Select Signal
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED, "NO BLOOD VESSEL SIGNAL FROM THE THD DOPPLER PROBE DEVICE DURING THD TREATMENT, SILENT". A NEW THD DOPPLER PROBE WAS USED AND THE TREATMENT WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE DEVICE WAS SENT TO TDH SPA (ITALY). ADD'L INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.
Remedial action
- Notification