The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation showed that the units passed all specific functional testing requirements.When unit is properly positioned and put under pressure unit would not have slipped.We were unable to duplicate the slippage.General maintenance and cleaning performed.The unit was recently repaired and will be returned to the customer not requiring any repairs.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.However, improper or suboptimal positioning on the patient can contribute to movement or slippage of the mayfield skull clamp.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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