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. AN INVESTIGATION OF THE EVENT AND INSPECTION OF THE DEVICE ARE BEING PERFORMED BY (B)(6). AN INITIAL TEST OF THE DEVICE SHOWED NO MALFUNCTION. FURTHER INVESTIGATION IS IN PROCESS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED. THE OWNERS MANUAL HAS MANY WARNINGS INCLUDING: IN PRINCIPLE EVERY CLIMBING PROCESS HAS TO BE COMPLETED. HOWEVER, IF THE SITUATION ARISES AND YOU MUST INTERRUPT THE CLIMBING PROCESS, LAY THE SCALAMOBIL WITH THE ATTACHED WHEELCHAIR BACKWARDS ON THE STAIRS. DUE TO THE SAFETY BRAKES, IT IS IMPOSSIBLE THAT THE SCALAMOBIL ROLLS OVER THE EDGE OF THE STEP.

Description of Event or Problem

THIS EVENT HAPPENED IN (B)(6). LIMITED INFORMATION WAS PROVIDED, (B)(6) IS ATTEMPTING TO GET FURTHER DETAILS. WHILE USING THE SCALAMOBIL TO TAKE THE PATIENT DOWNSTAIRS, THE DEVICE BECAME BLOCKED IN THE MIDDLE OF THE STAIRS CAUSING AN EVENT THAT RESULTED IN A NASAL BONE FRACTURE.

Additional Manufacturer Narrative

ALBER GERMANY COMPLETED THEIR EXAMINATION OF THE DEVICE. THEY FOUND THAT THE DEVICE FUNCTIONS PROPERLY WITHOUT ANY RESTRICTIONS OR MALFUNCTIONS ACCORDING TO ITS SPECIFICATIONS.

Description of Event or Problem

THIS EVENT HAPPENED IN GERMANY. LIMITED INFORMATION WAS PROVIDED, EUROPE IS ATTEMPTING TO GET FURTHER DETAILS. WHILE USING THE SCALAMOBIL TO TAKE THE PATIENT DOWNSTAIRS, THE DEVICE BECAME BLOCKED IN THE MIDDLE OF THE STAIRS CAUSING AN EVENT THAT RESULTED IN A NASAL BONE FRACTURE.