MalfunctionJAF
THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE
Received Mar 4, 2015 · Event occurred Jan 30, 2015
Report 3006680097-2015-00006 · MDR key 4597520
Device
Product problems
- Device Operates Differently Than Expected
- Noise, Audible
Patient
60 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE REPORTED PROBLEM IS COMPATIBLE WITH INTERFERENCES WITH OTHER EQUIPMENT / INSTRUMENTS. THE TECHNICAL INVESTIGATION IS STILL ONGOING. ADD'L INFO COULD BE SUPPLIED UPON ITS COMPLETION.
Description of Event or Problem
THE PROBE, WHEN CONNECTED TO THD EVOLUTION DEVICE AND ACTIVATED, PRODUCED STRONG DISTORTION SOUND AND NO DOPPLER SIGNAL WAS AUDIBLE. NO ERROR MESSAGES ON THD EVOLUTION DISPLAY. THE TREATMENT WAS THEN TERMINATED SUCCESSFULLY WITH ANOTHER THD DEVICE, WITH NO IMPACT ON THE PT OUTCOME.