SCALAMOBIL
Received May 22, 2015 · Event occurred Apr 28, 2015
Report 3004730072-2015-00001 · MDR key 4802223
Device
Product problems
- Improper or Incorrect Procedure or Method
- Device Handling Problem
Patient
12 YR
- Bruise/Contusion
Narrative
Description of Event or Problem
INFORMATION OF THE IMPORTER/CUSTOMER: (B)(6) (IMPORTER FMS) SPOKE WITH THE MOTHER WHO WAS OPERATING THE SCALA WITH HER DAUGHTER ((B)(6)) BEING TRANSPORTED IN THE CHAIR. THE SCALAMOBIL S35 IS MOUNTED TO A KI MOBILITY CAT 5 (16" WIDE) WHEELCHAIR). AMATO (DAUGHTER - WHEELCHAIR USER) AND MOM TUMBLED DOWN THE STAIRS. BOTH THE MOM AND DAUGHTER RECEIVED SOME BUMPS AND BRUISES. ACCORDING TO THE MOM, SHE FORGOT TO TIGHTEN THE ADJUSTMENT KNOBS ON THE HANDLES AND ALSO FORGOT TO REMOVE THE MANUAL WHEELS FROM THE WHEELCHAIR AS ADVISED IN THE USER MANUAL. THE COMBINATION OF THE TWO RESULTED IN THE ACCIDENT WHICH CAUSED THE SCALA AND CHAIR TO FALL DOWN THE STAIRS.