The device involved in this event was returned for evaluation and found to have passed manual and preset simulation test.The device was able to obtain readings indicating the customer's boards are functioning as designed.No product performance issue identified related to spo2 and pulse rate.A secondary finding indicated, the silence button was identified to be worn out and does not properly depress; silence button has no physical spring back resistance so the button occasionally triggers erratically when pressed, acting as though the button is being held down.A review of the service history for this device was performed and it was concluded that the device was in the field for four (4) months with no previous returns or reported issues prior to this event.
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