MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-05 for 3085 SP manufactured by Steris.
[1488974]
Upon unlocking bed, using manual release, post procedure and prior to turning pt, from the 9 o'clock position to the 12 o'clock position, so as to reverse her sedation the bed began to tip head first resulting in the pt's head hitting the floor and the base of the bed ending up in the air. Pt remained secured on the table and was removed to a liter. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015825 |
| MDR Report Key | 1678022 |
| Date Received | 2010-05-05 |
| Date of Report | 2010-04-29 |
| Date of Event | 2010-04-14 |
| Date Added to Maude | 2010-05-12 |
| 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 | 3 |
| 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 |
| Generic Name | AMSCO 3085 SP SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2010-05-05 |
| Model Number | 3085 SP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-05-05 |