MalfunctionJAF
THD SLINE DOPPLER PROBE 10 SHOTS NON STERILE
Received Dec 22, 2014 · Event occurred Nov 20, 2014
Report 3006680097-2014-00007 · MDR key 4373474
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED, "BEFORE THE CASE, THE THD DOPPLER PROBE WAS NEW, AND WHEN THE CASE STARTED, IT WAS NOT PICKING UP BLOOD VESSEL SIGNALS. THE SURGEON INCREASED PT BLOOD PRESSURE BUT NO SIGNAL COULD BE HEARD. THE SYSTEM WAS RESTARTED AND TRIED TO USE AGAIN THE SAME DOPPLER, BUT STILL NO SIGNAL WAS HEARD AND DETECTED. ANOTHER THD DOPPLER PROBE WAS USED AND IT WORKED."
Additional Manufacturer Narrative
THE DEVICE WAS SENT TO (B)(4). ADDITIONAL INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.
Remedial action
- Notification