Model Number ORG-9110A |
Device Problem
Communication or Transmission Problem (2896)
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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 07/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant signal loss.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 zm-531pa and zm-541pa telemetry transmitters were being used in conjunction with the org, but no serial numbers were provided by the customer.
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Event Description
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The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant signal loss.No patient harm reported.
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Event Description
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The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant signal loss.No patient harm 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) failed, and 8 telemetry transmitters were in constant signal loss.The unit was sent in for evaluation and repair.Service requested / performed: evaluation and repair.Investigation summary: nihon kohden repair center (nk rc) evaluated the reported device and was able to duplicate the issue of signal loss.This was found to be caused by the ip scheme the customer was using.When changed to a different ip scheme, the field signal strength was stronger and signal loss did not occur.As such, the signal loss is unlikely to be related to nk device malfunction but rather the customer's network environment.
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Search Alerts/Recalls
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