Model Number ORG-9110A |
Device Problems
Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that they are having intermittent signal loss issues and artifacts/noise occurring only in one specific department.The biomedical engineer states it is happening in the four (4) east wing and is isolated to just that location.Nihon kohden service engineer went on-site and tightened up three (3) way splitters and aac connections.All antenna's are working as expected.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.(b)(4).
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Event Description
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The biomedical engineer reported that they are having intermittent signal loss issues and artifacts/noise occurring only in one specific dept.The biomedical engineer states that it is happening in the four (4) east wing and is isolated to just that location.No patient harm was reported.
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Search Alerts/Recalls
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