FDA.reportPublic FDA data

MAUDE MDR 7806191

MDR report key
7806191
Report number
3004730072-2018-00006
Event key
0
Event type
3
Date received
2018-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR JASON FIEST
Address
ONE INVACARE WAY ELYRIA OH 44036 US
Phone
800-800-8003
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SCALAMOBIL S30 IQELEVATORALBER GMBHINGEU:SCALAMOBILS30IQSCALAMOBILS30IQY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2201. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.