PORTEX CUFF PRESSURE MONITORING
Received Apr 24, 2024 · Event occurred Mar 1, 2024
Report 9616567-2024-00067 · MDR key 19173461
Device
Generic name
Monitor, Airway Pressure Includes Gas And Or Aiarm
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
100/568/000
Lot number
4118580
Product problems
- Failure to Zero
- Pressure Problem
- Failure to Zero
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3L DAY UNKNOWN, MONTH AND YEAR KNOWN. H3 OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE.. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE EQUIPMENT'S PRESSURE GAUGE WAS NOT SET TO ZERO AND WAS NOT RESPONDING TO PRESSURE. THERE IS NO PATIENT INVOLVEMENT, HARM OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
INVESTIGATION OF THIS COMPLAINT WAS DONE BASED ON VIDEO WHICH WAS PROVIDED BY CUSTOMER. THE CUFF INFLATOR/PRESSURE GAUGE APPEARS WORN AND THERE IS A MISSING RUBBER EDGE ON THE DISPLAY. THE REPORTED COMPLAINT IS CONFIRMED. THE MOST PROBABLE CAUSE IS DUE TO A DROP OR DAMAGE TO THE DEVICE OR NO OCCLUDE OUTLET NOZZLE. IT CANNOT BE PROVED WITH CERTAINTY THEREFORE ROOT CAUSE OF THIS COMPLAINT REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.