MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-24 for SKYTRON 6500 * manufactured by Skytron.
[21385759]
Pt was in the or for eye surgery. The pt was placed on a locked or table. The table was unlocked to reposition it. The weight of the pt caused the table to tilt and hit the floor. The pt's head did not hit the floor but he received a jolt. The surgery was performed after this event. After surgery the pt was seen in the ed with no intervention needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 656655 |
| MDR Report Key | 656655 |
| Date Received | 2005-12-24 |
| Date of Report | 2005-12-23 |
| Date of Event | 2005-12-06 |
| Date Facility Aware | 2005-12-08 |
| Report Date | 2005-12-23 |
| Date Reported to FDA | 2005-12-23 |
| Date Reported to Mfgr | 2005-12-23 |
| Date Added to Maude | 2005-12-29 |
| 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 |
| 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 | SKYTRON |
| Generic Name | OR TABLE |
| Product Code | FSE |
| Date Received | 2005-12-24 |
| Model Number | 6500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 646141 |
| Manufacturer | SKYTRON |
| Manufacturer Address | 18440 TECHNOLOGY DR. STE 110 MORGAN HILL CA 95037 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-24 |