SCALAMOBIL S30 IQ

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN (B)(6), ALBER IS FILING THIS REPORT BECAUSE THE DEVICE WAS 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. A TECHNICAL DEFECT OF THE STAIRCLIMBER CAN BE EXCLUDED. THE STAIRCLIMBER WAS PURCHASED PRIVATELY BY THE PATIENT'S LEGAL REPRESENTATIVE IN AN ONLINE SHOP FOR USED MEDICAL PRODUCTS IN (B)(6). WE HAVE NO KNOWLEDGE OF WHETHER THE STAIRCLIMBER WAS PROPERLY INSTRUCTED AND HANDLED BY THE ONLINE SHOP OR BY THE LEGAL REPRESENTATIVE TO THE DRIVING SERVICE OR CAREGIVER. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS AN OPERATING ERROR.

Description of Event or Problem

ON (B)(6) 2020 REPORTED BY BROTHER OF THE PATIENT TO ALBER (B)(4). WHILST THE PATIENT WAS TRANSPORTED DOWN THE STAIRS IN HIS OWN HOME BY THE DRIVING SERVICE/CAREGIVER, THE PATIENT FELL FORWARDS (SIX STEPS) SEATED IN THE WHEELCHAIR WITH ATTACHED SCALAMOBIL. THE PATIENT WAS EXAMINED IN HOSPITAL, ABRASIONS AND BRUISES WERE FOUND, NO STATIONARY HOSPITALIZATION. THE ALTERNATING DRIVING SERVICES /CAREGIVERS WERE INSTRUCTED IN THE HANDLING OF THE STAIR CLIMBER BY THE LEGAL REPRESENTATIVE (BROTHER OF PATIENT). THE DEVICE WAS PURCHASED PRIVATELY BY THE LEGAL REPRESENTATIVE IN AN ONLINE SHOP FOR USED MEDICAL DEVICES.