SCALAMOBIL S35

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN (B)(6), ALBER IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. A DETAILED INVESTIGATION OF THE STAIRCLIMBER WAS CARRIED OUT. THE STAIRCLIMBER FUNCTIONS PROPERLY ACCORDING TO OUR SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS AN OPERATING ERROR BY NOT OBSERVING THE INSTRUCTION FOR USE.

Description of Event or Problem

THE OPERATOR (HUSBAND OF THE PATIENT) INFORMED THE ALBER DISTRICT MANAGER THAT HE WAS UNABLE TO MAINTAIN THE BALANCE OF THE STAIRCLIMBER DURING A STAIR DESCENT IN HIS OWN HOME AND THAT THE STAIRCLIMBER INCLUDING WHEELCHAIR AND PATIENT FELL 3-4 STEPS FORWARD DOWN THE STAIRS. THE PATIENT (WIFE OF THE OPERATOR) SUFFERED A MILD BRAIN CONCUSSION AND HAD TO BE ADMITTED TO HOSPITAL. THE PATIENT HAS ALREADY BEEN RELEASED FROM THE HOSPITAL. THE STAIRCLIMBER WAS DAMAGED BY THE FALL AND THE LEFT BRAKE HAS BROKEN OFF.