MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-20 for O.R. TABLE, RADIOGRAPHIC EXTENSION 2080L R+F EXTENSION * manufactured by Steris Corp..
[183871]
While lying prone on the radiographic extension board attached to or table model 2080l, pt fell to the floor. The pt consciously broke his own fall with his arms out-stretched, while simultaneously being assisted by anesthesiologist. Attempts to re-stabilize pt and extension board on the table were unsuccessful. There was no adverse pt outcome. Examination of extension board found locking/hooking brackets to be dull and worn. Board removed from svc. Epidural w/steroids and fluoro: procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 246687 |
| MDR Report Key | 246687 |
| Date Received | 1999-10-20 |
| Date of Report | 1999-09-20 |
| Date of Event | 1999-09-16 |
| Date Facility Aware | 1999-09-17 |
| Report Date | 1999-09-20 |
| Date Added to Maude | 1999-11-01 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | O.R. TABLE, RADIOGRAPHIC EXTENSION |
| Generic Name | O.R. TABLE, RADIOGRAPHIC EXTENSION |
| Product Code | FSE |
| Date Received | 1999-10-20 |
| Returned To Mfg | 1999-09-22 |
| Model Number | 2080L R+F EXTENSION |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 238975 |
| Manufacturer | STERIS CORP. |
| Manufacturer Address | 2720 GUNTER PARK DRIVE MONTGOMERY AL 36109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-10-20 |