MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-18 for HAUSTED MBC000ST N/A manufactured by Steris Corporation.
[15489607]
A patient was turning from side position to back. The bed tilted vertically onto head, with the wheels off the floor. The patient was helped off of the bed onto the floor by the nurse and technologist to prevent a patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 584668 |
| MDR Report Key | 584668 |
| Date Received | 2005-03-18 |
| Date of Report | 2005-03-18 |
| Date of Event | 2005-01-18 |
| Report Date | 2005-03-18 |
| Date Reported to FDA | 2005-03-18 |
| Date Added to Maude | 2005-03-25 |
| 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 | 0 |
| 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 | HAUSTED |
| Generic Name | MAMMOGRAPHY BIOPSY CHAIR |
| Product Code | FZK |
| Date Received | 2005-03-18 |
| Model Number | MBC000ST |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 574500 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 927 LAKE ROAD MEDINA OH 44258 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-18 |