The customer reported that a patient was harmed while using this drain.They clarified that they do not believe the drain was responsible and that the staff misused it.They reported that the staff clamped the patient tube, which prevented drainage and caused a pneumothorax to form in the patient.The customer requested that getinge provide some in-service training to their staff.This training was provided.The customer did not return the device, send pictures, or provide a lot number of the device so neither a device evaluation nor a device history evaluation can be completed.However, because the customer said the device performed as intended and that it was user error that caused the event, it cannot be confirmed that the device was nonconforming to its specifications.The device was not operated according to the provided instructions and the customer informed us that the operators' misuse of the device was the cause of the event.Additional training on the use of the device was provided per the customer's request.All evidence provided by the complainant and reviewed during the investigation indicates that the device performed within specification and the labeling was adequate.The root-cause of this complaint is user error.H3 other text: not available for return.
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