(b)(4).It was reported that during unknown procedure, the patient developed a skin burn approximately 2 inches.The device was evaluated and device is within specification.The device was subjected to the preventive maintenance, safety and functional testing and all tests passed.No malfunction found on device.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.
|