MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-17 for RT300-SL FA100052 IN212372 manufactured by Restorative Therapies Inc..
[19529758]
Patient has congenital neuromuscular hypotonia and congenital heart aplasia. Patient was cycling when the system reported a "pad off" error on multiple channels. The mother of the patient then reported that her son had a spasm in his lower extremities. Shortly afterwards he requested oxygen because he had difficulty breathing (patient has low congenital neuromuscular hypotonia and congenital heart aplasia). Patient was hospitalized for one week while o2 sats remained low. During hospitalization physicians found nothing wrong with him after extensive work-up.
Patient Sequence No: 1, Text Type: D, B5
[19651523]
Evaluated the stimulation cable and discovered a frayed conductor in contact with the conductor of another wire within the cable causing a short circuit condition. Modified controller software to detect any cable faults before stimulation is applied to the electrodes. Evaluated controller software modification. Validation report identified all short circuit conditions; two stimulating electrodes in contact, stimulating electrode in contact with ground, non-stimulating electrode in contact with ground, etc. Result in a "pad-off" error with a brief (<2 us) pre-pulse delivered which is perceptible on an able-bodied subject but not considered noxious. This is the only event of this kind reported in 6 years and (b)(4) recorded therapy sessions of use with the rt300. We are confident the software modification will prevent further events. We have also implemented additional actions which will prevent shorts in our stimulation cable and inappropriate current stimulation from our stimulation circuitry if a short does occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004733458-2011-00001 |
| MDR Report Key | 2343142 |
| Report Source | 04 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-10-18 |
| Date Mfgr Received | 2011-11-01 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2011-11-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR SCOTT SIMCOX |
| Manufacturer Street | 907 SOUTH LAKEWOOD AVE. |
| Manufacturer City | BALTIMORE MD 21224 |
| Manufacturer Country | US |
| Manufacturer Postal | 21224 |
| Manufacturer Phone | 8006099166 |
| Manufacturer G1 | RESTORATIVE THERAPIES INC. |
| Manufacturer Street | 907 SOUTH LAKEWOOD AVE. |
| Manufacturer City | BALTIMORE MD 21224 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21224 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT300-SL |
| Generic Name | FES CYCLE ERGOMETER |
| Product Code | GZI |
| Date Received | 2011-11-17 |
| Returned To Mfg | 2011-11-01 |
| Model Number | FA100052 |
| Catalog Number | IN212372 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESTORATIVE THERAPIES INC. |
| Manufacturer Address | 907 SOUTH LAKEWOOD AVE. BALTIMORE MD 21224 US 21224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-11-17 |