LITTLE WAVE
Received Jan 16, 2025
Report 3005905321-2025-00001 · MDR key 21166922
Device
Generic name
Little Wave Flip
Manufacturer
Ki MobilityProduct problems
- Mechanical Problem
- Insufficient Device Problem Information
- Mechanical Problem
- Insufficient Device Problem Information
Patient
NA · Male
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
CHILD WAS SITTING IN THE WHEELCHAIR. THE CHILD HAS VERY HIGH TONE AND WAS STRAPPED IN THE WHEELCHAIR, PLAYING AROUND AND THE FRONT LEFT CASTER ARM BOLTS BROKE AND FELL OFF. HE HAS VERY HIGH TONE AND LEFT CASTER ARM BOLTS BROKE OFF CAUSING HIM AND THE CHAIR TO TIP OVER AS HE WAS STRAPPED IN AND HIT HIS HEAD ON A CLOTHING RACK AND RECEIVED A LACERATION ON THE LEFT SIDE OF HIS HEAD ABOVE HIS EAR.
Additional Manufacturer Narrative
TO STRENGTHEN THE FASTENER, KI MOBILITY IMPROVED THE DESIGN OF FASTENER HARDWARE. ORIGINAL HARDWARE PASSED ALL REQUIRED TESTING.
Description of Event or Problem
CHILD WAS SITTING IN THE WHEELCHAIR. THE CHILD HAS VERY HIGH TONE AND WAS STRAPPED IN THE WHEELCHAIR, PLAYING AROUND AND THE FRONT LEFT CASTER ARM BOLTS BROKE AND FELL OFF. HE HAS VERY HIGH TONE AND LEFT CASTER ARM BOLTS BROKE OFF CAUSING HIM AND THE CHAIR TO TIP OVER AS HE WAS STRAPPED IN AND HIT HIS HEAD ON A CLOTHING RACK AND RECEIVED A LACERATION ON THE LEFT SIDE OF HIS HEAD ABOVE HIS EAR.
Additional Manufacturer Narrative
THE COMPONENTS INVOLVED HAVE NOT BEEN RETURNED YET SO WE COULD NOT DETERMINE IF THE PARTS ARE DEFECTIVE.THIS IS THE INITIAL REPORT AND WE WILL UPDATE WHEN THE PARTS ARE RETURNED AND EVALUATED TO DETERMINE IF THE COMPONENT WAS DEFECTIVE.
Remedial action
- Replace