MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-04 for ALBER SCALAMOBIL S35 EU:1097 1097 manufactured by Alber Gmbh.
[107379079]
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 were performed. The device was received in as is condition. Inspection revealed external damage consistent with a crash caused by forward tilt such as the device falling down the staircase. The examination showed no signs of any technical defects. The investigation confirmed that the damage was caused because of the fall, the were no signs of defect/malfunction prior to the event. After replacing the external parts damaged by the fall, it was confirmed the scalamobil functioned as it should with no issues or defects. The dealer stated the cause of the event was user error. The attendant did not maintain the center of gravity during use and let go of the scalamobil. There are multiple warnings in the owner's manual including: "tilt the scalamobil towards you until it is at an optimum angle to the stairs and the stair climber with the passenger is well balanced. Maintain this angle during the entire climb up/down the stairs. " the function checks section of the manual includes: "for safety reasons, always test the brakes before climbing a staircase. This check must be performed without attached wheelchair and while the scalamobil is switched off. If one or both brakes fail to work properly, do not operate the scalamobil under any circumstances. "
Patient Sequence No: 1, Text Type: N, H10
[107379080]
The patient was being taken down the stairs in the scalamobil. The scalamobil was connected to a wheelchair with seat shell. The attendant alleges that the brake was not functioning. The patient and the attendant fell down the stairs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2018-00005 |
| MDR Report Key | 7487684 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-05-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ALBER SCALAMOBIL S35 |
| Generic Name | ELEVATOR |
| Product Code | ING |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-04-09 |
| Model Number | EU:1097 |
| Catalog Number | 1097 |
| Operator | OTHER CAREGIVERS |
| Device Availability | R |
| 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, GERMANY 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-04 |