SCALAMOBIL

Description of Event or Problem

NARRATIVE TRANSLATION: ACCORDING TO THE CAREGIVER (OPERATOR OF THE DEVICE), THE EVENT OCCURRED WHILE OPERATING A STAIRCLIMBER WITH THE PATIENT SEATED IN THE ATTACHED WHEELCHAIR. ON THE LAST TWO STEPS, THE CAREGIVER REPORTEDLY LOST BALANCE OF THE STAIRCLIMBER, RESULTING IN A FALL DOWN THE REMAINING STEPS WITH THE PATIENT. DUE TO THE FALL, THE PATIENT SUSTAINED BRUISES WHICH WERE TREATED WITH SHORT-TERM OUTPATIENT (AMBULATORY) CARE.

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN GERMANY. ALBER IS FILING THIS REPORT BECAUSE THE DEVICE WAS MARKETED AND SOLD IN THE U.S. ALBER PERFORMED AN INVESTIGATION OF THE AFFECTED UNIT. THE INVESTIGATION INCLUDED VISUAL INSPECTION OF THE RETURNED DEVICE WITHOUT DISASSEMBLY. NO WEAR OR DAMAGE WAS OBSERVED ON CHAINS, BRAKES, BRAKE PADS, OR DRIVE WHEELS. FUNCTIONAL TESTING CONFIRMED PROPER OPERATION OF CONTROLS AND BRAKING SYSTEM. STAIR TESTING WITH A TEST LOAD (ASCENT AND DESCENT) SHOWED NO MALFUNCTIONS; DEVICE OPERATED AS INTENDED. NO DEVICE-RELATED CAUSE IDENTIFIED. THE EVENT IS ATTRIBUTED TO UNINTENTIONAL USER ERROR (LOSS OF BALANCE DURING DESCENT). THE INSTRUCTIONS FOR USE INCLUDE GUIDANCE FOR SAFE OPERATION ON STAIRS, INCLUDING DESCENT.