MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-08 for AMSCO BF80-000 * manufactured by Steris Corporation.
[3513832]
Armboard became detached from the or bed during procedure. When the armboard came away from the rail of the bed, it needed to be held by anesthesiologist until a replacement was connected to bed. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3187052 |
| MDR Report Key | 3187052 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-03-08 |
| Date of Event | 2013-01-03 |
| Report Date | 2013-03-08 |
| Date Reported to FDA | 2013-03-08 |
| Date Reported to Mfgr | 2013-05-28 |
| Date Added to Maude | 2013-06-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | AMSCO |
| Generic Name | TABLE, OPERATING ROOM |
| Product Code | BWN |
| Date Received | 2013-03-08 |
| Model Number | BF80-000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| 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 | 2013-03-08 |