[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