OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR
Received Oct 21, 2019 · Event occurred Sep 5, 2019
Report 3007409280-2019-00044 · MDR key 9216422
Device
Product problems
- Calibration Problem
- Calibration Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. DEVICE EVALUATION FOUND THE TIMING WAS OFF. THE TIMING WAS ADJUSTED. THE DEVICE WAS CALIBRATED. LEAK TEST AND SUCTION ACCURACY WAS TESTED AND PASSED. THE GAUGE TEST, LEAK TEST - SUPPLY/PATIENT SIDE, REGULATION TEST IN BOTH MODES ALL PASSED. THE FINAL VISUAL INSPECTION WAS GOOD. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, THE REPORTED ISSUE WAS MOST LIKELY DUE TO THE PRESSURE SENSOR FALLING OUT OF CALIBRATION. THIS WAS NOT RELATED TO THE PREVIOUS REPAIR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE DEVICE GAUGE GOES ALL THE WAY AROUND WHEN THE SUCTION IS TURNED TO FULL AND ITS PORT IS OPEN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.