Model Number ORG-9100A |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme)reported that the multiple patient receiver (org) has weak signal and signal loss reported on telemetry transmitters.They switched the org settings to diversity mode, and replaced the defective antenna on our b-loop to resolve issue.No patient harm was 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.Concomitant medical device: the following device(s) were being used in conjunction with the org: central nurse's station: model: cns-9701a; sn: (b)(4).Telemetry transmitter: model: zm-540pa; sn: (b)(4).Telemetry transmitter: model: zm-540pa; sn: (b)(4).
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Event Description
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The biomedical engineer (bme)reported that the multiple patient receiver (org) has weak signal and signal loss reported on telemetry transmitters.They switched the org settings to diversity mode, and replaced the defective antenna on our b-loop to resolve issue.No patient harm was reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) had a weak signal.The telemetry transmitters experienced intermittent signal loss at the central nurse's station (cns).They switched the org settings to diversity mode and replaced the defective antenna on the b-loop to resolve the issue.No patient harm was reported.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps and advised customer to check the antenna for the org and verify that the mode was set to diversity.The customer followed the troubleshooting steps provided by nk ts finding one (1) bad antenna, replaced it, and changed the setting to diversity.No further issues of signal loss were reported.The cause of the signal loss was likely a defective antenna which was used to receive the signal from the transmitters.Antennas are a third-party product.Antenna failure is likely a result of hardware failure.Hardware failure could come as a result of physical, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.There is no evidence of an nk device malfunction.
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Event Description
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The biomedical engineer (bme) reported that the multiple patient receiver (org) had a weak signal.Signal loss was reported with the telemetry transmitters.They switched the org settings to diversity mode and replaced the defective antenna on the b-loop to resolve the issue.No patient harm was reported.
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Search Alerts/Recalls
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