SCALAMOBIL

Additional Manufacturer Narrative

THE INCIDENT OCCURRED IN GERMANY. ALBER IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. AS OF THE DATE OF THIS REPORT, THE DEVICE REMAINS IN POLICE CUSTODY, AND THE CASE HAS BEEN REFERRED TO THE APPROPRIATE PUBLIC PROSECUTOR'S OFFICE. THE DEVICE UNDERWENT A PRELIMINARY EVALUATION BY THE POLICE AND WAS FOUND TO BE FULLY FUNCTIONAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE EVENT IS BELIEVED TO BE ASSOCIATED WITH POTENTIAL USER/OPERATOR ERROR. THE INVESTIGATION IS ONGOING, AND FURTHER UPDATES WILL BE PROVIDED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

NARRATIVE TRANSLATION: BASED ON CURRENTLY AVAILABLE INFORMATION, PATIENT WAS BEING TRANSPORTED UP A STAIRCASE IN AN APARTMENT BUILDING USING A SCALAMOBIL. DURING THE TRANSFER, THE OPERATOR REPORTED LOSING BALANCE. THE PATIENT AND THE DEVICE SUBSEQUENTLY FELL DOWN THE STAIRCASE. THE PATIENT SUSTAINED DUE TO THE FALL FATAL INJURIES AND DIED. AT THE TIME OF THIS REPORT, OFFICIAL INVESTIGATIONS ABOUT THE CIRCUMSTANCES OF THE INCIDENT ARE ONGOING.