MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-12 for SCALAMOBIL S30 IQ manufactured by Alber Gmbh.
[178735791]
The incident occurred in (b)(6), alber is filing this report because the device was also marketed and sold in the u. S. A detailed investigation of the stairclimber was carried out. The stairclimber functions properly according to our specifications. A technical defect of the stairclimber can be excluded. The stairclimber was purchased privately by the patient's legal representative in an online shop for used medical products in (b)(6). We have no knowledge of whether the stairclimber was properly instructed and handled by the online shop or by the legal representative to the driving service or caregiver. 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
[178735792]
On (b)(6) 2020 reported by brother of the patient to alber (b)(4). Whilst the patient was transported down the stairs in his own home by the driving service/caregiver, the patient fell forwards (six steps) seated in the wheelchair with attached scalamobil. The patient was examined in hospital, abrasions and bruises were found, no stationary hospitalization. The alternating driving services /caregivers were instructed in the handling of the stair climber by the legal representative (brother of patient). The device was purchased privately by the legal representative in an online shop for used medical devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2020-00003 |
| MDR Report Key | 9698710 |
| Report Source | OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2005-04-06 |
| Date Added to Maude | 2020-02-12 |
| 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 S30 IQ |
| Generic Name | SCALAMOBIL S30 IQ |
| Product Code | ING |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-04 |
| Model Number | S30 IQ |
| 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 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-12 |