MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-03 for SCALAMOBIL S35 EU:1520415 1520415 manufactured by Alber Gmbh.
[131983162]
The incident occurred in (b)(6); invacare is filing this report because the device is also marketed and sold in the u. S. The scalamobil has not been returned for an evaluation. An investigation was performed by using the same model scalamobil and wheelchair in a simulation of the setting where the accident occurred. The allegation of the scalamobil rolling away could not be duplicated when on even ground. No alleged malfunction/deficiency was found with the device. Based on the information provided and the investigation, it was determined the most probable cause of the event was the system was not parked on even ground. The manual states: you should park the scalamobil with manual wheelchair on even ground with aligned wheels. If more information is received, follow up record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[131983163]
The operator of the scalamobil transferred the patient (sitting in a wheelchair) down a staircase with 8 steps. There were no issues with the stair-climbing process; the scalamobil ran without problems. The operator left the patient alone (sitting in the wheelchair and still connected to the scalamobil) in the street area near the curb; the patient rolled away and fell over the curb onto her face. She suffered a broken cheekbone and had to be admitted to hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2019-00001 |
| MDR Report Key | 8214360 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2017-04-04 |
| Date Added to Maude | 2019-01-03 |
| 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 | 2019-01-03 |
| Model Number | EU:1520415 |
| Catalog Number | 1520415 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization | 2019-01-03 |