MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for ANDAGO manufactured by Hocoma Ag.
[96016915]
One customer in usa reported a broken handrail on the andago v2. 0. (handrails are optional components). It occured while servicing the medical device, not while a therapy. No patient training ongoing so nobody (patient, user and 3rd persons) were injured. However the potential harm, could occur during patient setup and release, which could lead to a serious injury. (safety related). As this case is related to patient safety, hocoma decided to initiate a mdr in the us. We have identified 19 (nineteen) andago v2. 0 products in usa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003781275-2017-00002 |
| MDR Report Key | 7143901 |
| Date Received | 2017-12-22 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-22 |
| 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. KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | HOCOMA AG |
| Manufacturer Street | INDUSTRIESTRASSE 4 |
| Manufacturer City | VOLKETSWIL, CH-8604 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-8604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANDAGO |
| Generic Name | POWERED EXCERCISER |
| Product Code | BXB |
| Date Received | 2017-12-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOCOMA AG |
| Manufacturer Address | INDUSTRIESTRASSE 4 VOLKETSWIL, CH-8604 SZ CH-8604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-22 |