SCALAMOBIL S35
Received Apr 11, 2019
Report 3004730072-2019-00002 · MDR key 8503904
Device
Generic name
Elevator, Wheelchair, Portable
Manufacturer
Alber GmbhModel number
EU:1520415Catalog number
1520415
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Death
- Death
Narrative
Additional Manufacturer Narrative
THIS INCIDENT OCCURRED IN (B)(6) INVOLVING A PRODUCT MANUFACTURED BY ALBER (B)(4) IN (B)(4). INVACARE IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. THE PATIENT'S HUSBAND STATED THAT THE DEVICE DID NOT MALFUNCTION. HE RELATED NEITHER THE WHEELCHAIR THAT WAS ATTACHED TO THE SCALAMOBIL NOR THE SCALAMOBIL FELL DOWN THE STAIRS DURING THE ACCIDENT. THE WHEELCHAIR REMAINED ATTACHED TO THE SCALAMOBIL. THE PATIENT WAS NOT WEARING A HARNESS SYSTEM WHICH IS OFFERED AS AN OPTIONAL ACCESSORY. THE HUSBAND HAS GIVEN PERMISSION FOR THE SCALAMOBILE TO BE EVALUATED, AS OF THE DATE OF THIS REPORT THE SCALAMOBIL HAS NOT BEEN RETURNED. THE DATE OF THE ORIGINAL EVENT IS NOT KNOWN. IF MORE INFORMATION IS RECEIVED, A FOLLOW-UP RECORD WILL BE FILED.
Description of Event or Problem
ALBER (B)(4) RECEIVED A LETTER FROM THE PATIENT¿S HUSBAND ON (B)(6) 2019. HE RELATES THE PATIENT WAS SITTING IN A PYRO START WHEELCHAIR WHICH WAS ATTACHED ON THE SCALAMOBIL. HE WAS USING THE DEVICE TO TRANSPORT HER DOWN A WIDE STAIRCASE AT A RESTAURANT. HE CAME TO THE SIDE OF THE WALL AND THE DEVICE STOPPED. HIS WIFE CAME OUT OF THE CHAIR AND FELL DOWN FIVE STEPS LANDING ON A STONE FLOOR. SHE WAS UNCONSCIOUS AND WAS TAKEN TO A CLINIC IN (B)(6). ON (B)(6) 2019 THE HUSBAND REPORTED THE PATIENT HAD REMAINED IN A COMA UNTIL (B)(6) WHEN SHE PASSED AWAY.