SCALAMOBIL S35

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN (B)(6); INVACARE IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. THE SCALAMOBIL HAS NOT BEEN RETURNED FOR AN EVALUATION. AN INVESTIGATION WAS PERFORMED BY USING THE SAME MODEL SCALAMOBIL AND WHEELCHAIR IN A SIMULATION OF THE SETTING WHERE THE ACCIDENT OCCURRED. THE ALLEGATION OF THE SCALAMOBIL ROLLING AWAY COULD NOT BE DUPLICATED WHEN ON EVEN GROUND. NO ALLEGED MALFUNCTION/DEFICIENCY WAS FOUND WITH THE DEVICE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT WAS DETERMINED THE MOST PROBABLE CAUSE OF THE EVENT WAS THE SYSTEM WAS NOT PARKED ON EVEN GROUND. THE MANUAL STATES: YOU SHOULD PARK THE SCALAMOBIL WITH MANUAL WHEELCHAIR ON EVEN GROUND WITH ALIGNED WHEELS. IF MORE INFORMATION IS RECEIVED, FOLLOW UP RECORD WILL BE FILED.

Description of Event or Problem

THE OPERATOR OF THE SCALAMOBIL TRANSFERRED THE PATIENT (SITTING IN A WHEELCHAIR) DOWN A STAIRCASE WITH 8 STEPS. THERE WERE NO ISSUES WITH THE STAIR-CLIMBING PROCESS; THE SCALAMOBIL RAN WITHOUT PROBLEMS. THE OPERATOR LEFT THE PATIENT ALONE (SITTING IN THE WHEELCHAIR AND STILL CONNECTED TO THE SCALAMOBIL) IN THE STREET AREA NEAR THE CURB; THE PATIENT ROLLED AWAY AND FELL OVER THE CURB ONTO HER FACE. SHE SUFFERED A BROKEN CHEEKBONE AND HAD TO BE ADMITTED TO HOSPITAL.