PURITAN BENNETT
Received Jan 29, 2026 · Event occurred Jan 14, 2026
Report 2182208-2026-01533 · MDR key 24214939
Device
Generic name
Cuff, Tracheal Tube, Inflatable
Manufacturer
Medtronic, Inc.Model number
180-03Catalog number
180-03
Product problems
- Pressure Problem
Patient
86 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE CUFF RINGS AND DISPLAYED A ZERO PRESSURE, NO COMPENSATION. THE BALLOON WAS CHECKED WITH PRESSURE GAUGE AND INDICATES THAT THE PRESSURE HAD NO ISSUE. THE TUBE WAS REMOVED AND REPLACED.