MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for SAFEGAIT 360? SG360-L- 40 manufactured by Gorbel Inc..
[57867266]
On (b)(6) 2016 a student therapist was working with a patient using the safegait 360 degree system. The patient was seated and the therapist was holding the spreader bar in her hand after having lowered the strap via the positioning control with the intent to detach the harness straps from the spreader bar. She noticed that the spreader bar appeared "loose" and then the spreader bar detached from clip that connects it to the strap. The spreader bar remained in the therapist's hand and the patient was unaffected. Prior to the incident, there was nothing noted as being out of the ordinary by the customer and there was no visual indication that there was a potential issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000278354-2016-00001 |
| MDR Report Key | 6034680 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2016-10-17 |
| 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 | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES GILL |
| Manufacturer Street | 590 FISHERS RUN |
| Manufacturer City | FISHERS NY 144530593 |
| Manufacturer Country | US |
| Manufacturer Postal | 144530593 |
| Manufacturer Phone | 5859246249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFEGAIT 360? |
| Generic Name | POWERED EXERCISE EQUIPMENT |
| Product Code | BXB |
| Date Received | 2016-10-17 |
| Returned To Mfg | 2016-02-26 |
| Model Number | SG360-L- 40 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GORBEL INC. |
| Manufacturer Address | 590 FISHERS RUN FISHERS NY 144530539 US 144530539 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-17 |