MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for SCALAMOBIL S30 IQ EU:SCALAMOBILS30IQ SCALAMOBILS30IQ manufactured by Alber Gmbh.
[117901010]
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.
Patient Sequence No: 1, Text Type: N, H10
[117901011]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2018-00006 |
| MDR Report Key | 7806191 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-07-25 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2010-11-30 |
| Date Added to Maude | 2018-08-22 |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT 72461 |
| Manufacturer Country | US |
| 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 | 2018-08-22 |
| Model Number | EU:SCALAMOBILS30IQ |
| Catalog Number | SCALAMOBILS30IQ |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | VOR DEM WEISSEN STEIN 21 ALBSTADT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-22 |