PORTEX CUFF PRESSURE MONITORING
Received Aug 22, 2024 · Event occurred Jul 1, 2024
Report 3012307300-2024-07929 · MDR key 20030783
Device
Generic name
Monitor, Airway Pressure (includes Gauge And/or Alarm)
Manufacturer
Smiths Medical Asd, Inc.Catalog number
54-05-000JJP
Product problems
- Decrease in Pressure
- Decrease in Pressure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION FOUND A DEFORMED POINTER SHAFT ON THE GAUGE. DURING FUNCTIONAL TESTING, IT WAS CONFIRMED THAT THE PRESSURE VALUE ON THE CUFF PRESSURE GAUGE DECREASED EVEN WHEN PRESSURE WAS APPLIED. THERE IS LEAKING FROM THE HOUSING OF MAIN UNIT. BASED ON THE OBSERVATIONS, IT IS PRESUMED THAT THE CAUSE OF THIS EVENT WAS AN IMPACT, SUCH AS A FALL, APPLIED TO THE CUFF PRESSURE GAUGE BODY. THE CAUSE OF THE OCCURRENCE IS DUE TO USER USAGE. THE HOUSING ASSY AND BASEPLATE WERE REPLACED TO CORRECT THE ISSUE. CUFF PRESSURE GAUGE DEVICE PASSED ALL FUNCTIONAL TESTS AFTER REPAIR. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.
Description of Event or Problem
IT WAS REPORTED THAT THE PRESSURE DECREASED. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. BIHAO (B)(6) 2024.
Additional Manufacturer Narrative
D4: UDI INFORMATION IS UNKNOWN. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.