Additional manufacuring narrative: other, other text: the returned device was evaluated.During visual inspection, the bend relief sleeve was found to be damaged and the latch is missing.The device passed functional testing and the module maintains communication and measurement with cable bending.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit had no product performance issues related to spo2 and pulse rate.The device functions as designed regarding accuracy and measurements.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
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