Model Number GZ-140PA |
Device Problems
Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); 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 07/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.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 gz-140pa telemetry transmitter.Central nurse's station: model: cns-6201a, sn: (b)(4).
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Event Description
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The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm reported.
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Event Description
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The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm was reported.Investigation summary: nihon kohden technical support (nk ts) reached out to clinical information technical support (cits) who was in the process of rebooting the universal gateway (ug) to troubleshoot another complaint.The ug reboot resolved the issue and the gz transmitter began to show waveforms again.The root cause is determined to be the facility's network environment.
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Search Alerts/Recalls
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