MalfunctionJAF
THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE
Received Oct 30, 2014 · Event occurred Sep 24, 2014
Report 3006680097-2014-00004 · MDR key 4261598
Device
Product problems
- Communication or Transmission Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE DOCTOR OPENED A NEW THD OPERATION BOX, TOOK OUT A NEW THD DOPPLER PROBE AND CONNECTED IT TO THE THD EVOLUTION DEVICE. THE PROBE DID NOT GIVE ANY SIGNAL DURING OPERATION, IT ONLY HISSED. THE DOCTOR RESTARTED THD EVOLUTION, BUT THE PROBLEM (HISS) REMAINED. THE DOCTOR TOOK ANOTHER THD DOPPLER PROBE (FROM ANOTHER BOX) AND COMPLETED OPERATION SUCCESSFULLY.
Additional Manufacturer Narrative
WE ARE WAITING TO RECEIVE THE DEVICE AT THE HEADQUARTERS OF (B)(6), IN ORDER TO COMPLETE THE INVESTIGATION.
Remedial action
- Notification