MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-11 for SCALAMOBIL S35 EU:1520415 1520415 manufactured by Alber Gmbh.
[141598975]
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.
Patient Sequence No: 1, Text Type: N, H10
[141598976]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2019-00002 |
| MDR Report Key | 8503904 |
| Report Source | CONSUMER |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2019-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT 72461 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 72461 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALAMOBIL S35 |
| Generic Name | ELEVATOR, WHEELCHAIR, PORTABLE |
| Product Code | ING |
| Date Received | 2019-04-11 |
| Model Number | EU:1520415 |
| Catalog Number | 1520415 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | VOR DEM WEISSEN STEIN 21 ALBSTADT 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2019-04-11 |