PORTEX CUFF PRESSURE MONITORING
Received Jun 24, 2024 · Event occurred May 1, 2024
Report 3012307300-2024-05352 · MDR key 19594758
Device
Generic name
Pressure Monitoring (air/gas) Kit
Manufacturer
Smiths Medical Asd, Inc.Catalog number
54-05-000JJP
Product problems
- Pressure Problem
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUFF OF DEVICE CANNOT BE PRESSURIZED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
AFTER FURTHER REVIEW, THIS PRODUCT WAS FOUND TO BE A PFG. THE DEVICE DOES NOT HAVE A 510K OR SALES IN THE UNITED STATES, NOR ARE THERE ANY SUBSTANTIALLY SIMILAR DEVICES SOLD IN THE US. THEREFORE, NO REGULATORY REPORTING IS REQUIRED TO THE FDA FOR THIS ISSUE. MFR# 3012307300-2024-05352 WILL BE CANCELLED.