SCALAMOBIL S30

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN GERMANY. ALBER IS FILING THIS REPORT BECAUSE THE DEVICE WAS MARKETED AND SOLD IN THE U.S. THIS REPORT IS FILED FOR THE INJURIES OF THE PATIENT. THE S30 MODEL WAS MARKETED FOR THE LAST TIME IN 2010 AND HAS BEEN REPLACED BY THE S35 MODEL. THE SPARE PARTS SUPPLY FOR THE S30 MODEL SERIES EXPIRED IN 2017. ALBER PERFORMED AN INVESTIGATION OF THE AFFECTED UNIT. A VISUAL INSPECTION AND TEST DRIVES ON STAIRCASE WERE PERFORMED. DURING THE VISUAL INSPECTION WITHOUT DISMANTLING THERE WERE NO SIGNS OF WEAR OR BREAKAGES ON THE CHAINS, BRAKES, BRAKE LININGS OR DRIVE WHEELS. THE LEFT HANDLE AND THE CENTER COVER ARE DAMAGED. THE DAMAGE TO THE LEFT HANDLE AND THE MIDDLE COVER WAS CAUSED MOST LIKELY DUE TO THE FALL. NO FAILURES WERE DETECTED DURING THE CLIMBING PROCESS (UPSTAIRS AND DOWNSTAIRS). NO INTERRUPTION OR BLOCKING OF THE DRIVE UNIT WAS DETECTED. THE FUNCTION OF THE STAIRCLIMBER WAS INCONSPICUOUS AND AS EXPECTED. THE ENTIRE DEVICE DID NOT SHOW ANY ABNORMALITIES THAT COULD HAVE CAUSED A MALFUNCTION OF THE STAIRCLIMBER.

Description of Event or Problem

NARRATIVE TRANSLATION THE INCIDENT OCCURRED ON (B)(6) 2024. WHILE CLIMBING UP THE STAIRS, A WHEEL ALLEGEDLY BLOCKED , CAUSING THE PATIENT AND OPERATOR TO FALL THREE STEPS DOWN THE STAIRS. AS A RESULT OF THE FALL, THE PATIENT AND THE OPERATOR (HUSBAND) SUSTAINED ABRASIONS AND BRUISES. THE OPERATOR WAS TREATED IN HOSPITAL AND THEN BY THE FAMILY DOCTOR. THE PATIENT WAS TREATED BY THE FAMILY DOCTOR.