MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-24 for SUPERSTAND HPS-2 manufactured by The Standing Company.
[3694615]
On (b)(6) 2013, the standing company was notified by e-mail that the client slipped out of his wheelchair and landed on his right knee. He was helped back into his chair by ems and left alone until his wife returned from work several hours later. Approximately three days later, the client complained of pain in his leg and was taken to the hospital. Tests showed that he had a broken femur just above the knee. Surgery was conducted to repair the femur. An investigation showed that the client has poor cognitive skills and is left alone for long periods of time during the day time. The client was alone when he attempted to stand in the standing wheelchair. The client admitted that he did not follow the safety protocol. The client's wife said that he failed to buckle his safety belt before standing. The client's wife also said that he failed to attach the tibia supports together before standing. The tibia supports are what keeps the clients legs from collapsing in the standing position. The standing company was not notified of the event until 19 days after it had occurred.
Patient Sequence No: 1, Text Type: D, B5
[10975470]
The client suffers from recurring cva's. He has neurosarcoidosis with brain dysfunction, quadriparesis on both the left and right side, and he has impaired core strength and balance. His cognitive skills are very poor. The standing company believes that the root cause of this event is from the client being left alone for long periods at a time with no supervision. The client is not capable of properly following safety protocol without adult supervision. After failing to attach his safety belt and tibias as directed in the safe operating procedures, he slipped out of the wheelchair onto the floor, resulting in injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007494904-2013-00002 |
| MDR Report Key | 3204221 |
| Report Source | 04 |
| Date Received | 2013-06-24 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-05-22 |
| Date Mfgr Received | 2012-06-10 |
| Device Manufacturer Date | 2012-09-21 |
| Date Added to Maude | 2013-07-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5848 DIXIE HIGHWAY |
| Manufacturer City | SAGINAW MI 48601 |
| Manufacturer Country | US |
| Manufacturer Postal | 48601 |
| Manufacturer Phone | 9897469100 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERSTAND |
| Generic Name | STAND UP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2013-06-24 |
| Model Number | HPS-2 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE STANDING COMPANY |
| Manufacturer Address | SAGINAW MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-24 |