Model Number ORG-9110A |
Device Problems
Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896); Output Problem (3005)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that they are experiencing signal loss and artifacts on several receivers on the multiple patient receiver (org).They are requesting 8 receiver cards to replace the current ones.No patient harm 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.Additional device information: concomitant medical device: the following devices were being used in conjunction with the org.Telemetry transmitter: model: zm-531pa, sn: (b)(4).
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Event Description
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The biomedical engineer reported that they are experiencing signal loss and artifacts on several receivers on the multiple patient receiver (org).They are requesting 8 receiver cards to replace the current ones.No patient harm reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported they were experiencing signal loss and artifacts for several receivers on the multiple patient receiver (org).No patient harm was reported.Investigation summary: the customer also stated there were artifacts on several receivers and they were requesting eight (8) receiver cards.Nihon kohden technical support (nk ts) requested additional information to provide the best possible support.However, the customer declined to provide the requested information.Nk ts initiated an exchange of the requested receiver cards.The org was not sent in, however, an evaluation of the receiver cards by nihon kohden repair center (nk rc) was performed when they were returned for exchange.They were able to duplicate the reported issue as well as find that noise (artifact) for spo2 and respiration was present.With the available information, the root cause is due to the defective receiver cards.The defective receiver cards were scrapped by nk rc and the customer was provided with the requested exchange of eight (8) receiver cards.A review of the serial number history for this org shows no recurrence of the reported issue.
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Event Description
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The biomedical engineer (bme) reported they were experiencing signal loss and artifacts for several receivers on the multiple patient receiver (org).No patient harm reported.
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Search Alerts/Recalls
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