MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-20 for SCALAMOBIL S30 IQ EU:SCALAMOBILS30IQ SCALAMOBILS30IQ manufactured by Alber Gmbh.
[106069516]
This event occurred in (b)(6). Invacare is filing this report because the device is also marketed and sold in the u. S. This report is for the attendant adverse event. The patient adverse event was filed separately. There is no evidence of a malfunction of the product. The stair geometry was complex requiring a trained and competent attendant using the scalamobil. The attendant in this case made a user error by not balancing the center of mass appropriately. Attendants are to receive documented training before using the device, the dealer was not able to provide a written training record for this attendant.
Patient Sequence No: 1, Text Type: N, H10
[106069517]
A scalamobil has fallen down the stairs while in use with a patient. Both the patient and the attendant were involved and had a stay in the hospital due to the accident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2018-00002 |
| MDR Report Key | 7447429 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2006-02-15 |
| Date Added to Maude | 2018-04-20 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT, GERMANY 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 S30 IQ |
| Generic Name | ELEVATOR |
| Product Code | ING |
| Date Received | 2018-04-20 |
| Model Number | EU:SCALAMOBILS30IQ |
| Catalog Number | SCALAMOBILS30IQ |
| Operator | OTHER CAREGIVERS |
| 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, GERMANY 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-20 |