The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices.The signal strength with power on was 15 and with power off was 4, 6, and 8.A power cycle did not fix the issue.Customer would like to send the device in for evaluation.A loaner device was sent to the customer.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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The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices.The signal strength with power on was 15 and with power off was 4, 6, and 8.A power cycle did not fix the issue.Customer sent in the device for evaluation.The reported problem of "signal loss on 3 tele" was duplicated, and the evaluation done by nihon kohden also found 4 other receivers having a spike on the spo2 waveform display.All malfunctioning parts were replaced.The unit was tested per operator's/service manual and the unit completed 24 hours of extended testing and operates to manufacturer's specifications.
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