inforMED
MalfunctionFIA

TREATMENT RECLINER

Received Apr 26, 2019 · Event occurred Jan 1, 2019

Report 0001831750-2019-00347 · MDR key 8554773

Device

Generic name

Chair, Dialysis, Unpowered, Without Scales

Catalog number

3500000710

Product problems

  • Device Fell
  • Device Fell

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 DAMAGED/BROKEN 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 IV POLE FELL IN AN UNINTENDED DIRECTION. THERE WAS NO PATIENT INVOLVEMENT.