MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-03 for SMALL MOBILE STANDER K13 manufactured by Rifton Equipment.
[57061003]
The device is almost 20 years old, long past the design life of 5 years. We are waiting for the return of the device to conduct further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[57061004]
It was reported that the client was using the stander when a structural component of the stander failed, allowing the body support to separate from the frame of the stander. The client reportedly fell backwards and hit his head, but was not injured.
Patient Sequence No: 1, Text Type: D, B5
[61224229]
The center panel had cracked, causing the body support to separate from the frame. It is likely that the cracks would have been visible before the failure occured. The product manual says: "inspect this product and accessories regularly for loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear. Immediately remove this product from use when any condition develops that might make operation unsafe. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319061-2016-00002 |
| MDR Report Key | 5994690 |
| Date Received | 2016-10-03 |
| Date of Report | 2016-09-06 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 1997-10-02 |
| Date Added to Maude | 2016-10-03 |
| 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. TRAVIS SCOTT |
| Manufacturer Street | 2032 RT 213 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456587722 |
| Manufacturer G1 | RIFTON EQUIPMENT |
| Manufacturer Street | 2032 RT 213 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL MOBILE STANDER |
| Generic Name | MOBILE STANDER |
| Product Code | KNL |
| Date Received | 2016-10-03 |
| Model Number | K13 |
| Catalog Number | K13 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | 2032 RT 213 RIFTON NY 12471 US 12471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-03 |