MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-20 for EASYSTAND EVOLV EVOLV MEDIUM NG50162 manufactured by Altimate Medical, Inc..
[3838946]
Received a call from a physical therapist requesting more info on the easystand evolv as she was putting together a checklist to train nurses that work with a pt. After further discussion, she informed me she had a pt that is required to be under 24 hours supervision and there had been a situation where one of the nurses caring for the pt had stepped away briefly to use the rest room; during this time the pt had a seizure while in the standing frame. The pt was found in a folded over position in the standing frame with the table pushed forward and as a result the pt suffered a fractured tibia. The therapist could not verify exactly how this occurred, but she did not believe there was anything wrong with the standing frame. She informed me that due to their internal protocol that the nurses could not use the standing frame until they were all properly trained, which is why she was putting together a checklist.
Patient Sequence No: 1, Text Type: D, B5
[11131103]
The therapist went to visit the home, review the product and create a checklist for the nurses that work with this pt. At that time, the therapist verified that the family had the product owner's manual which includes the instructions for use and maintenance instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2013-00003 |
| MDR Report Key | 3313766 |
| Report Source | 05 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2013-09-05 |
| 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 | STACEY FRANK |
| Manufacturer Street | 262 WEST FIRST ST. |
| Manufacturer City | MORTON MN 56270 |
| Manufacturer Country | US |
| Manufacturer Postal | 56270 |
| Manufacturer Phone | 5076976393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYSTAND EVOLV |
| Generic Name | 890.3110 |
| Product Code | ION |
| Date Received | 2013-08-20 |
| Model Number | EVOLV MEDIUM |
| Catalog Number | NG50162 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTIMATE MEDICAL, INC. |
| Manufacturer Address | 262 WEST FIRST ST. MORTON MN 56270 US 56270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-20 |