MalfunctionFIA
TREATMENT RECLINER
Received Apr 26, 2019 · Event occurred Jan 1, 2019
Report 0001831750-2019-00349 · MDR key 8554781
Device
Generic name
Chair, Dialysis, Unpowered, Without Scales
Manufacturer
Stryker Medical-kalamazooCatalog number
3500000710
Product problems
- Unintended Movement
- Unintended Movement
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE FOOTEND DID NOT ALWAYS LATCH. THERE WAS NO PATIENT INVOLVEMENT.