inforMED
MalfunctionIMP

AXIOM

Received May 15, 2025 · Event occurred Jun 25, 2023

Report 3005905321-2025-00004 · MDR key 22028079

Device

Generic name

Axiom

Manufacturer

Ki Mobility

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Female

  • Bone Fracture(s)
  • Bone Fracture(s)

Narrative

Description of Event or Problem

KI MOBILITY RECEIVED A FORMAL LEGAL DEMAND FOR SETTLEMENT LETTER ON (B)(6) 2025 FROM A LAW OFFICE IN REGARDS TO AN INCIDENT WHERE AN END USER ALLEGEDLY SUSTAINED SERIOUS INJURIES. THE LETTER STATED THAT THE SEAT COVER WAS NOT INSTALLED PROPERLY. VELCRO ON THE WHEELCHAIR USED TO AFFIX THE. SEAT COVER RAN PARALLEL WITH THE REAR WHEELS. HOWEVER, THE VELCRO ON THE SEAT COVER RAN PERPENDICULAR TO THE WHEELCHAIR'S REAR WHEELS. AS A RESULT, THE SEAT CUSHION EASILY SLID OFF THE WHEELCHAIR, CREATING AN UNREASONABLY DANGEROUS CONDITION.

Additional Manufacturer Narrative

THE LETTER FROM THE ATTORNEY STATES THAT ON (B)(6) 2023, THE END USER WAS USING HER QUICKIE WHEELCHAIR WITH A KI MOBILITY CUSHION (CUSHION MODEL IS NOT SPECIFIED LIMITING ANY INVESTIGATION). THE SEAT CUSHION ALLEGEDLY SLIPPED FORWARD SUDDENLY WHILE SHE WAS DESCENDING ON A SLIGHT DECLINE. IT AS STATED IN THE LETTER THE SEAT COVER WAS NOT INSTALLED PROPERLY. VELCRO ON THE WHEELCHAIR USED TO AFFIX THE SEAT COVER RAN PARALLEL WITH THE REAR WHEELS. HOWEVER, THE VELCRO ON THE SEAT COVER RAN PERPENDICULAR TO THE WHEELCHAIR'S REAR WHEELS. THIS IMPEDED THE VELCRO'S EFFICACY IN SECURING THE SEAT CUSHION IN PLACE. WHEN THE SEAT CUSHION WAS INSTALLED, THIS WOULD HAVE BEEN VISIBLE AND SHOULD HAVE BEEN CORRECTED AT INSTALLATION. KI MOBILITY INSTALLS VELCRO ON THE SEAT CUSHIONS AND KI MOBILITY SUPPLIED WHEELCHAIRS. KI MOBILITY AXIOM USER MANUAL STATES "IF YOUR WHEELCHAIR SLING OR SEAT PAN DOES NOT HAVE HOOK AND LOOP CLOSURES, OR THEY DO NOT ALIGN WITH THE CUSHION, YOU SHOULD CONSULT YOUR AUTHORIZED KI MOBILITY SUPPLIER OR YOUR CLINICIAN TO ENSURE THE CUSHION IS APPROPRIATE."