MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-28 for S35 SCALAMOBLIE manufactured by Alber Gmbh.
[122027362]
The alber representative reported that the patient's family was only aware of the aide being evaluated at two separate urgent care facilities, and on both occasions the doctors found no evidence of injuries and released her without treatment. The aide is now stating that she went to a hospital er and ended up in the icu due to a lacerated spleen and punctured lung. The patient? S family requested medical records, but the aide has not provided any documentation to confirm the injuries. The alber representative advised that the patient has multiple sclerosis, and she has little body control, so when she is reclined in the scalamobil it is unlikely for her to be able to move forward. He does not believe that she moved in any way that would have contributed to the incident. The patient weighs approximately 200 pounds, which is under the maximum user weight of 308 pounds. The stairway on which the incident occurred has 6 steps total, but the patient and aide did not fall down all 6 steps. The weight shifted as they were partway down the stairs; the exact step where the event occurred is unknown. The alber representative advised that when he delivered the scalamobil on 06/11/2018, he inspected the stairs and operated the scalamobil on them, and no issues were identified. The steps met the necessary requirements. The alber representative also operated the device on the steps after the incident occurred, and it functioned properly without any issues. The underlying cause of the incident cannot be definitively determined; however, it was likely a result of use error. It is the responsibility of the aide to maintain the balance of the scalamobil during operation, and the aide did not receive proper training prior to using the device. The aide was not present for training at the time of delivery, and she did not receive training at a later date, even though the alber representative advised that training was required prior to operation of the scalamobil. The scalamobil user manual states, "the operation of the scalamobil without prior proper instruction is prohibited. Only persons instructed by an authorized dealer or an agent of alber are authorized to operate the scalamobil. " a product malfunction has not been identified. In addition to the testing performed onsite at the patient's home, the scalamobil was brought back to alber usa for an evaluation, and it functioned properly. It will be sent to alber (b)(4) for further analysis. The patient also sustained a serious injury, which was reported in a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[122027363]
An alber representative reported that the patient's aide was attempting to transport the patient down the steps using the scalamobil s35 when the weight shifted forward, and both the aide and patient tumbled down the steps. The aide fell over top of the scalamobil, and she allegedly sustained a lacerated spleen and punctured lung, and she was in the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2018-00008 |
| MDR Report Key | 7918242 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-05 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2018-02-07 |
| Date Added to Maude | 2018-09-28 |
| 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, BADEN-W |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S35 SCALAMOBLIE |
| Generic Name | ELEVATOR, WHEELCHAIR, PORTABLE |
| Product Code | ING |
| Date Received | 2018-09-28 |
| Returned To Mfg | 2018-10-09 |
| Model Number | S35 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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, BADEN-W?RTTEMBERG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |