SCALAMOBIL S39
Received Oct 23, 2019 · Event occurred Sep 6, 2019
Report 3004730072-2019-00008 · MDR key 9222702
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
WITH REPORT# 3004730072-2019-00007 ALBER (B)(6) FILED THE INJURY CAUSED TO THE PATIENT. ADDITIONALLY WE FILE THIS REPORT FOR THE CAUSED INJURY TO THE OPERATOR. THE SCALAMOBIL WAS INSPECTED. THE SCALAMOBIL FUNCTIONS PROPERLY WITHOUT ANY RESTRICTIONS ACCORDING TO OUR SPECIFICATIONS. A TECHNICAL DEFECT OR MALFUNCTION OF THE DEVICE WHICH CAUSED TO THE EVENT CAN BE EXCLUDED. WE MAKE THE EDUCATED GUESS THAT THE EVENT WAS CAUSED BY AN OPERATING ERROR OF THE OPERATOR.
Description of Event or Problem
MEDICAL SUPPLY STORE INFORMED ALBER (B)(4) THAT THE HUSBAND OF THE CUSTOMER TRIED TO TRANSPORT HIS WIFE DOWN A 12-STEP STONE STAIRCASE WITH THE SCALAMOBIL S39. AFTER REACHING THE FOURTH STEP AND TRANSITION TO THE FIFTH, THE SMALL WHEELS ON THE DEVICE DID NOT FOLLOW WHILST THE LARGE WHEELS MOVED FURTHER. AS A RESULT THE DEVICE LOST ITS GRIP AND THE HUSBAND TRIED TO PULLING BACK THE DEVICE TO PREVENT A FALL, BUT THIS DID NOT SUCCEED AND BOTH PERSONS (WIFE ON THE DEVICE, HUSBAND AS OPERATOR) FELL DOWN THE REMAINING STAIRS AND SUSTAINED SERIOUS INJURIES (PATIENT BROKEN FIBULA, OPERATOR BROKEN LOWER ARM) RESULTING IN A FOUR-DAY HOSPITAL STAY.
Remedial action
- Inspection