MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for OPERATING ROOM TABLE manufactured by American Sterilizer Company.
[3156]
An operating room table, moved during a surgical procedure, despite being locked in place pre-operatively. L the table was re-locked, but continued to move when leaned uponinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4797 |
| MDR Report Key | 4797 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-03-04 |
| Date of Event | 1992-02-03 |
| Date Facility Aware | 1992-02-03 |
| Report Date | 1992-03-04 |
| Date Reported to Mfgr | 1992-03-04 |
| Date Added to Maude | 1993-06-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | FSE |
| Date Received | 1992-07-31 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4513 |
| Manufacturer | AMERICAN STERILIZER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |