The customer reported that the org has a noisy ecg and respiration signal.Receiver 1, 5, and 7 are bad.A loaner org was shipped to the customer however did not function correctly.A second loaner was shipped to the customer which also did not operate properly.When customer tried to install the second loaner org they experienced communication loss issues.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
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Manufacturer narrative: the customer reported that the org has a noisy ecg and respiration signal.Receiver 1, 5, and 7 are bad.A loaner org was shipped to the customer however did not function correctly.A second loaner was shipped to the customer which also did not operate properly.When customer tried to install the second loaner org they experienced communication loss issues.The device has been returned to nka, however, the device was misplaced and never evaluated.Device seems to be misconfigured.The loaner was sent out mis-configured and did not have smoothing enabled, as customer did not request to have smoothing on the device.Customer was sent device with smoothing enabled, which resolved the issue.Due to the age of this complaint additional information necessary to conduct an investigation is not readily available.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.Device not evaluated.
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