The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.Initial reporter telephone number exceeded the maximum allowable characters, the telephone number is as follows: (b)(6).
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Additional manufacturing narrative: other, other text: the returned sensor was evaluated.During evaluation, the cable passed visual inspection; eeprom contents were verified and no problems were observed through this verification. during continuity testing, the cable failed due to a defective emitter causing low voltage on the red diode.The sensor is functioning, however the low voltage on the red diode caused the spo2 values to fluctuate from 43 to 99%.No stable spo2 measurement value was provided.No issues were detected with regard to pulse rate values.Initial reporter telephone number exceeded the maximum allowable characters, the telephone number is as follows: (b)(6).
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