MalfunctionFIA
TREATMENT RECLINER
Received Apr 27, 2020 · Event occurred Jan 1, 2020
Report 0001831750-2020-00422 · MDR key 10001253
Device
Generic name
Chair, Dialysis, Unpowered, Without Scales
Manufacturer
Stryker Medical-kalamazooCatalog number
3500000710
Product problems
- Unintended System Motion
- Unintended System Motion
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 AND THE ISSUE WAS CONFIRMED; THERE WAS A BENT/DEFORMED COMPONENT. THE DEVICE WAS REPAIRED AND RETURNED. 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 DEVICE HAD PHANTOM MOTION. THERE WAS NO PATIENT INVOLVEMENT.