MalfunctionJAF
THD SLIDE DISPOSABLE STERILE DOPPLER PROBE
Received Nov 11, 2014 · Event occurred Sep 1, 2014
Report 3006680097-2014-00006 · MDR key 4315083
Device
Generic name
Doppler Probe Disposable
Manufacturer
Thd Spa-correggio (re) - ItalyModel number
800063Catalog number
NA
Product problems
- No Audible Alarm
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING A CASE, THERE WAS NO SOUND FROM THE THD DOPPLER PROBE DEVICE. THE STAFF NOTICED THE SIGNAL IN THE DISPLAY OF THE REVOLUTION DEVICE, BUT NO SOUND COULD BE HEARD OUT OF IT. THEN, A NEW THD DOPPLER PROBE WAS USED AND THE TREATMENT INITIATED AND COMPLETED AS USUAL. A "WARNING" MESSAGE WAS DISPLAYED BY THE THD REVOLUTION, ALTHOUGH THE "WARNING NUMBER" WAS NOT REPORTED.
Additional Manufacturer Narrative
THE DEVICE WAS SENT TO THD SPA (B)(4). ADDITIONAL INFORMATION COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.