SCALACOMBI

Additional Manufacturer Narrative

THIS EVENT OCCURED IN GERMANY. ALBER IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. ALBER PERFORMED AN INVESTIGATION OF THE RETURNED DEVICE. THE INVOLVED DEVICE ARRIVED AT ALBER DAMAGED. A FUNCTIONAL TEST WAS PERFORMED ON A STAIRCASE AND DESPITE THE DAMAGES THE FUNCTION OF THE STAIRCLIMBER WAS INCONSPICUOUS. WE ASSUME THAT THE FALL WAS CAUSED/CONTRIBUTED BY AN OPERATING/HANDLING ERROR.

Description of Event or Problem

NARRATIVE TRANSLATION: ON THE DAY OF THE EVENT, THE STAIRCLIMBER WAS OPERATED BY THE PATIENT'S DAUGHTER. WHILE CLIMBING UP THE STAIRS, A WHEEL BROKE OFF, CAUSING THE STAIRCLIMBER AND THE PATIENT TO FALL FORWARD ONE STEP DOWN THE STAIRS AGAINST AN APARTMENT ENTRANCE DOOR. AS A RESULT OF THE FALL, THE PATIENT FELL ON HIS FACE AND SUFFERED A LOWER LEG FRACTURE. THE PATIENT WAS ADMITTED TO HOSPITAL FOR THE NIGHT.