6257 XPEDITION POWERED CHAIR
Received Oct 27, 2025
Report 0001831750-2025-99385 · MDR key 23393244
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625700000000
Product problems
- Sharp Edges
- Sharp Edges
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 IS PENDING EVALUATION. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: APPROPRIATE TERM/CODE NOT AVAILABLE / RESULTS PENDING COMPLETION OF INVESTIGATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Additional Manufacturer Narrative
THE DEVICE THAT WAS PENDING EVALUATION WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS) 1 DEVICE: RAIL/FRACTURE PROBLEM.
Description of Event or Problem
NO NEW INFORMATION.