MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for STERIS 5085 BEACH CHAIR manufactured by Steris Corporation.
[143681262]
Pt was intubated on operating room table. Back of table was being moved into the chair position. The back of the chair went to the floor and the pt fell backwards hitting his head on the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086272 |
| MDR Report Key | 8565315 |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-12 |
| Date Added to Maude | 2019-04-30 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERIS 5085 BEACH CHAIR |
| Generic Name | TABLE, OPERATING-ROOM, PNEUMATIC |
| Product Code | FWW |
| Date Received | 2019-04-29 |
| Model Number | 5085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-29 |