TREATMENT RECLINER

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 EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BACKREST MOVES UNEXPECTEDLY OR QUICKLY/FORCEFULLY. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN, BUT NO SERIOUS ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem

NO NEW INFORMATION.

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/MECHANICAL PROBLEM IDENTIFIED.