MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-17 for CHAIR HYDROLICS SIMULTANEOUS RECLINE * manufactured by Steris Corporation.
[384441]
Pt was transferred from the bed to the cardiac chair. During the process, the pt fell to the floor. Upon review with the staff, it appeared the chair brake may have been "toe touched" by the staff when reaching over the pt. This may have allowed the chair to move away from the bed. Pt transferred to referring hosp for further care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 560885 |
| MDR Report Key | 560885 |
| Date Received | 2004-12-17 |
| Date of Report | 2004-12-09 |
| Date of Event | 2004-11-28 |
| Date Facility Aware | 2004-11-28 |
| Report Date | 2004-12-09 |
| Date Reported to FDA | 2004-12-09 |
| Date Reported to Mfgr | 2004-12-08 |
| Date Added to Maude | 2004-12-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIR HYDROLICS SIMULTANEOUS RECLINE |
| Generic Name | CARDIAC CHAIR |
| Product Code | BYN |
| Date Received | 2004-12-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 550593 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-12-17 |