MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-04 for SMALL DYNAMIC STANDER K130 manufactured by Rifton Equipment.
[30690083]
Visual analysis of the failed component suggests that there would likely have been visible cracking of the part well before the failure that resulted in this incident. Such cracking would be obvious to a user complying with the instructions in the device manual to periodically inspect the device for cracks. The product manual instructions say: "to prevent structural failure, which may result in serious injury or death: 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
[30690084]
It was reported that as staff was putting the student into the mobile stander, a structural component of the stander failed, allowing the body support to separate from the frame of the stander.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-2015-00001 |
| MDR Report Key | 5202090 |
| Date Received | 2015-11-04 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2015-03-06 |
| Date Added to Maude | 2015-11-04 |
| 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 | TRAVIS SCOTT |
| Manufacturer Street | 2032 RT 213 PO BOX 903 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456587722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SMALL DYNAMIC STANDER |
| Generic Name | MOBILE STANDER |
| Product Code | IPL |
| Date Received | 2015-11-04 |
| Returned To Mfg | 2015-10-28 |
| Model Number | K130 |
| Catalog Number | K130 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | 2032 RT 213 PO BOX 903 RIFTON NY 12471 US 12471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |