MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-05 for AMSCO STERIS FRACTURE TABLE P-1446655-648 NA manufactured by Amsco (american Sterilizer Company) Steris.
[2939990]
Pt was positioned on a fracture table for repair of left hip fracture. At the end of the procedure, during the final stages of skin closure when the pt anesthesia was being reversed, the pt moved. Without a reliable method of being able to use a safety strap because of the shape of a fracture table, she could have fallen to the floor. Her near fall event was averted. Upon reviewing the event, it was noted that falls from fracture tables are reported in the literature. Event is reported because of concern about securing pt torso to this table is of concern.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027533 |
| MDR Report Key | 2826900 |
| Date Received | 2012-11-05 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-07-05 |
| Date Added to Maude | 2012-11-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO STERIS FRACTURE TABLE |
| Generic Name | AMSCO STERIS FRACTURE TABLE |
| Product Code | JEB |
| Date Received | 2012-11-05 |
| Model Number | P-1446655-648 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMSCO (AMERICAN STERILIZER COMPANY) STERIS |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-05 |