MalfunctionJAF
THD SLIDE DOPPLER PROBE 10 SHOTS OF NON STERILE
Received Jan 14, 2015 · Event occurred Dec 10, 2014
Report 3006680097-2015-00003 · MDR key 4432732
Product problems
- No Device Output
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED, " AT THE CASE STARTED, THERE WAS NO BLOOD VESSEL SIGNAL AND SOUND WE CAN HEAR FROM THE THD DOPPLER PROBE. WE TRIED TO TURN TO DIFFERENT POINTS USING THE PROCTOSCOPE AND INCREASE BLOOD PRESSURE BUT STILL NOT SIGNAL AND SOUND". A NEW THD DOPPLER PROBE WAS USED AND THE TREATMENT WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE TECHNICAL INVESTIGATION IS STILL ONGOING. ADDITIONAL INFO COULD BE PROVIDED UPON ITS COMPLETION.
Remedial action
- Notification