Model Number ORG-9110A |
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 11/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that the multiple patient receiver (org) and multiple telemetry transmitters were in communication loss.The error lamp was lit on the org that was showing communication loss.Nihon kohden technical support (tech support) had them power cycle the org twice, but the error lamp was still on.Then they had them initialize the org but the error lamp is still on.The unit is being returned for evaluation.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 model information: concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni) for the telemetry transmitters, as attempts to obtain information were made but information was not provided.Central nurse's station model: cns-6201a sn: (b)(4).Telemetry transmitters model: ni sn: ni.
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Event Description
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The biomedical engineer reported that the multiple patient receiver (org) and multiple telemetry transmitters were in communication loss.The error lamp was lit on the org that was showing communication loss.Nihon kohden technical support (tech support) had them power cycle the org twice, but the error lamp was still on.Then they had them initialize the org but the error lamp is still on.The unit is being returned for evaluation.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) and multiple telemetry transmitters were in comm loss.The error lamp on the org was lit.Nihon kohden technical support (nk ts) advised the customer to power cycle the org twice, but the error lamp was still lit.Then they asked them to initialize the org but there was still no change.The customer returned the unit for evaluation.No patient harm was reported.Service requested / performed: evaluation / repair.Investigation summary: the reported communication loss was not duplicated by nihon kohden repair center (nk rc) so a root cause cannot be determined.The customer reported a recurrence upon receiving the evaluated device.The customer reported that they would perform more testing but did not report any further issues with the device.The communication loss is likely resolved.The age of the org was 6 years at the time of the incident.As nk rc was not able to duplicate the issue, the comm loss is likely to be intermittent in nature.The error light is commonly caused by corrupt software.The customer has not reported any further issues or followed up.
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Event Description
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The biomedical engineer (bme) reported that the multiple patient receiver (org) and multiple telemetry transmitters were in comm loss.The error lamp on the org was lit.Nihon kohden technical support (nk ts) advised the customer to power cycle the org twice, but the error lamp was still lit.Then they asked them to initialize the org but there was still no change.The customer returned the unit for evaluation.No patient harm was reported.
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Search Alerts/Recalls
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