SCALAMOBIL S30 IQ

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). INVACARE IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. THIS REPORT IS FOR THE ATTENDANT ADVERSE EVENT. THE PATIENT ADVERSE EVENT WAS FILED SEPARATELY. THERE IS NO EVIDENCE OF A MALFUNCTION OF THE PRODUCT. THE STAIR GEOMETRY WAS COMPLEX REQUIRING A TRAINED AND COMPETENT ATTENDANT USING THE SCALAMOBIL. THE ATTENDANT IN THIS CASE MADE A USER ERROR BY NOT BALANCING THE CENTER OF MASS APPROPRIATELY. ATTENDANTS ARE TO RECEIVE DOCUMENTED TRAINING BEFORE USING THE DEVICE, THE DEALER WAS NOT ABLE TO PROVIDE A WRITTEN TRAINING RECORD FOR THIS ATTENDANT.

Description of Event or Problem

A SCALAMOBIL HAS FALLEN DOWN THE STAIRS WHILE IN USE WITH A PATIENT. BOTH THE PATIENT AND THE ATTENDANT WERE INVOLVED AND HAD A STAY IN THE HOSPITAL DUE TO THE ACCIDENT.