PORTEX CUFF PRESSURE MONITORING
Received Dec 17, 2024 · Event occurred Jul 1, 2024
Report 3012307300-2024-14170 · MDR key 20956697
Device
Generic name
Monitor, Airway Pressure (includes Gauge And/or Alarm)
Manufacturer
Smiths Medical Asd, Inc.Catalog number
54-05-000JJP
Lot number
UNKNOWN
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION FOUND NO ABNORMALITIES. DURING THE FUNCTIONAL TESTING, THERE WERE NO ABNORMALITIES FOUND IN THE PRODUCT AND IT WORKED NORMALLY. WHEN THE TUBE THAT CAME WITH THE PRODUCT WAS CONNECTED TO THE MAIN UNIT, THE REPORTED PHENOMENON WAS REPRODUCED. THE CAUSE IS AN AIR LEAK IN THE ATTACHED TUBE. THE CUFF PRESSURE GAUGE DEVICE PASSED ALL FUNCTIONAL TESTS.
Description of Event or Problem
IT WAS REPORTED THAT "THE NEEDLE COMES DOWN." THERE WAS PATIENT INVOLVEMENT. PER INVESTIGATION: DURING THE FUNCTIONAL TESTING, THERE WERE NO ABNORMALITIES FOUND IN THE PRODUCT, AND IT WORKED NORMALLY. WHEN THE TUBE THAT CAME WITH THE PRODUCT WAS CONNECTED TO THE MAIN UNIT, THE REPORTED PHENOMENON WAS REPRODUCED. THE CAUSE WAS AN AIR LEAK IN THE ATTACHED TUBE.