Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803 the device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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The st is worn leaking water from the sides, sides of the display screen is cracked, heavy built up debris in water hose, solenoid and hpc wire harness, damaged power drive board, it delays activation when fc is pressed.Damaged and faulty parts have been replaced, unit have been calibrated and tested to factory's specs.No other faults found.
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