MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-04-10 for RIFTON DYNAMIC STANDER K15 manufactured by Rifton Equipment.
[2591863]
We understand that a structural component of the stander failed, allowing the body support mechanism to separate from the frame of the stander. This apparently caused the user of the device to fall and sustain a slight fracture of her left arm.
Patient Sequence No: 1, Text Type: D, B5
[9955283]
The device in question is nearly 13 years old and had changed hands at least once. It appears to have been poorly maintained and in bad repair prior to the incident. Preliminary analysis suggests that there would likely have been visible cracking of the part well before the alleged failure that resulted in this incident. Such cracking would be obvious to a user complying with the instruction in the device manual to periodically inspect the device for cracks. It is possible that the device was used to a manner for which it was not intended. The product manual instructions say: "periodically inspect for cracks, breaks, loose or missing parts, and/or malfunctions. Remove the product from service when any condition develops that might make operation unsafe. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319558-2012-00001 |
| MDR Report Key | 2538218 |
| Report Source | 01,05 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-03-09 |
| Date Mfgr Received | 2012-03-09 |
| Device Manufacturer Date | 1999-08-21 |
| Date Added to Maude | 2012-04-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RYAN BURKE |
| Manufacturer Street | 2032 RT 213 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON DYNAMIC STANDER |
| Generic Name | KNL - BOARD, SCOOTER, PRONE |
| Product Code | KNL |
| Date Received | 2012-04-10 |
| Model Number | K15 |
| Catalog Number | K15 |
| Lot Number | K1519990821AB |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | RIFTON NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-10 |