MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jul 8, 2026 · Event occurred Jun 11, 2026
Report 0001526350-2026-00799 · MDR key 25756110
Device
Product problems
- Difficult or Delayed Activation
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT BEFORE SURGERY, THERE WAS A DELAY IN GETTING THE UNIT TO START, TAKES MULTIPLE ATTEMPTS BEFORE IT WILL START RUNNING AND IS NOT RUNNING ON FULL POWER. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER UNIT WAS USED IN PLACE OF THIS ONE. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE,