The device was returned to the factory for evaluation.The device showed no signs of clinical usage and no evidence of blood.A visual inspection was conducted.No defects were observed.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident.An electrical evaluation was performed.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2, reference adapter cable and reference power supply.The device passed the pre-cautery test.A polyfuse electrical test was performed with the same reference power supply, adapter cable and hemopro 2; the polyfuse successfully shut off power to the heater after prolonged periods of time and activated after the device cooled.Based upon the evaluation results, the reported complaint was not able to be confirmed.
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