MalfunctionFRK
NARROW TREATMENT RECLINER
Received Jan 28, 2025 · Event occurred Oct 1, 2024
Report 0001831750-2025-00167 · MDR key 21252366
Device
Generic name
Chair, Examination And Treatment
Manufacturer
Stryker Medical-kalamazooCatalog number
3500000705
Product problems
- Device Fell
- Device Fell
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOOT SECTION COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.