MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for SCALAMOBIL S35 manufactured by Alber Gmbh.
[177991647]
The incident occurred in germany, alber is filing this report because the device is also marketed and sold in the u. S. The scalamobil has been returned for an evaluation. An investigation was performed. The brake wheel is not broken but deformed. The visible damages (deformation of the brake wheel) to the stairclimber were caused by tipping to the side. Despite of the visible damages (deformation of the brake wheel) no alleged malfunction/deficiency was found with the device. Based on the information provided and the investigation, it was determined that the most probable cause of the event was an operating error.
Patient Sequence No: 1, Text Type: N, H10
[177991648]
Description received via repair accompanying letter (09 january 2020) : error of brake wheel. Right is loose person fell and left brake wheel is broken. Update 28 january 2020 phone call between operator and alber gmbh: operator (husband of the patient) informed that on (b)(6) 2019 the stairclimber tipped sideways away during a stair descent at the home of the daughter. The operator was able to prevent the stairclimber including wheelchair and patient from falling down the staircaise (2-3 steps). The patient was strapped in her wheelchair during the descent. The patient suffered a contusion on one finger. No medical intervention or hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2020-00001 |
| MDR Report Key | 9675746 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2017-03-28 |
| Date Added to Maude | 2020-02-06 |
| 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. CHRISTOPH HAUSCHEL |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT 72461 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72461 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALAMOBIL S35 |
| Generic Name | ELEVATOR,WHEELCHAIR,PROTABEL |
| Product Code | ING |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-01-09 |
| Model Number | S35 |
| 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 ALBSTADT 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |