MalfunctionDPW
DOPPLER MODEL 812
Received Aug 27, 2025 · Event occurred Jan 19, 2025
Report 22902318 · MDR key 22902318
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Parks Medical Electronics, Inc.Model number
812-1Product problems
- Defective Device
Patient
42 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING SURGERY, THE DOPPLERS AND PROBES USED IN THE OPERATING ROOM WERE FOUND TO BE FAULTY. DESPITE PLACING THE PROBE DIRECTLY ON TOP OF THE BLOOD VESSEL, THE EQUIPMENT FAILED TO FUNCTION PROPERLY. MULTIPLE ATTEMPTS WERE MADE, INVOLVING THREE DIFFERENT PROBES AND THREE DIFFERENT DOPPLER BOXES, TO FIND A WORKING COMBINATION. EVEN WHEN A FUNCTIONAL COMBINATION WAS FOUND, THE RESULTS WERE BARELY ACCEPTABLE. BATTERY DEPLETION WAS RULED OUT AS ALL THREE BOXES WERE FULLY CHARGED.