MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-08 for 3080 RL OPERATING ROOM TABLE BE 587283 N/A manufactured by American Sterilizar Company (amsco).
[243]
Ordered and received 18 new surgical tables from amsco. About two weeks after use, three tables developed hydraulic fluid leaks. Upon investigation by amsco it was discoveredd that several tables during a certain period of time had a table shaft that was thinner in the middle then on the ends stretching the "o" rings. When the "o" rings stretched, the hydraulic fluid leaks out and the table becomes non-operationaldevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: other, invalid data. Results of evaluation: none or unknown, invalid data. Conclusion: device failed during assembly. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 495 |
| MDR Report Key | 495 |
| Date Received | 1992-04-08 |
| Date of Report | 1992-03-30 |
| Date of Event | 1992-03-27 |
| Report Date | 1992-03-30 |
| Date Reported to FDA | 1992-03-30 |
| Date Added to Maude | 1992-05-05 |
| 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 |
| Brand Name | 3080 RL OPERATING ROOM TABLE |
| Generic Name | 3080 RL SURGICAL TABLE |
| Product Code | FWW |
| Date Received | 1992-04-08 |
| Model Number | BE 587283 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 488 |
| Manufacturer | AMERICAN STERILIZAR COMPANY (AMSCO) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-04-08 |