TRI-ANIM AIR OXYGEN BLENDER SMALL
Received Oct 22, 2019 · Event occurred Sep 23, 2019
Report 3007409280-2019-00045 · MDR key 9219344
Device
Generic name
Precision Medical Oxygen Regulator
Manufacturer
Precision Medical, Inc.Model number
FOTA1000Product problems
- Improper Flow or Infusion
- No Apparent Adverse Event
- Improper Flow or Infusion
- No Apparent Adverse Event
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. DEVICE SENT IN DUE TO THE BLEEDER LEAKING MORE THAN NORMAL. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND THE DEVICE NEEDED A COMPLETED OVERHAUL AND REQUIRED RE-CALIBRATING. THE OVERHAUL WAS COMPLETED AND THE DEVICE WAS CALIBRATED TO OEM SPECIFICATION. THE ROOT CAUSE WAS DETERMINED TO BE AGED PARTS. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR THE BLEEDER LEAKS MORE THAN NORMAL. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.