ZIMMER AIR DERMATOME
Received Jun 9, 2026 · Event occurred Apr 1, 2026
Report 0001526350-2026-00644 · MDR key 25443631
Device
Product problems
- Calibration Problem
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT WAS RETURNED FOR PREVENTATIVE MAINTENANCE. DURING MAINTENANCE IT WAS DISCOVERED THAT SWIVEL AND MOTOR NEEDED REPLACEMENT AS THE DEVICE WAS LEAKING AIR FROM SWIVEL, AND CALIBRATION READING 0 WAS OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.