The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.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.Manufacturer references file (b)(4).
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The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.
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