inforMED
MalfunctionIOR

KI MOBILITY

Received May 23, 2016 · Event occurred Apr 16, 2016

Report 3005905321-2016-01923 · MDR key 5673856

Device

Generic name

Focus Cre

Manufacturer

Ki Mobility

Model number

N/A

Catalog number

N/A

Lot number

N/A

Product problems

  • Bent
  • Break

Patient

40 YR

  • Fall
  • Head Injury
  • Fall
  • Head Injury

Narrative

Description of Event or Problem

CUSTOMER CLAIMS THAT THE USER'S WIFE HAD HIM OUTSIDE AND WAS PULLING HIS CHAIR BACKWARDS UP A LITTLE RAMP AND WHEN SHE SET IT DOWN ON THE CASTERS, ONE OF THEM COMPLETELY BROKE/BENT UNDER THE CHAIR. USER FELL OUT OF THE CHAIR AND HIT HIS HEAD ON THE CONCRETE. THIS OCCURRED WHEN 1 CASTER BROKE/BENT WHEN CHAIR WAS SET BACK DOWN ON THEM. THIS HAPPENED ON (B)(6) 2016 OUTSIDE OF THE USERS FACILITY.