Model Number GF-210RA |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the multigas unit was not showing any gas readings.The customer tried using this unit in a different room, but the issue persisted.No harm or injury was reported.The customer will be sending this unit in for a repair.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.
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Event Description
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The customer reported that the multigas unit was not showing any gas readings.
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Event Description
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The customer reported that the multigas unit was not showing any gas readings.
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Manufacturer Narrative
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Details of complaint: on 1/8/2020 customer stated gas unit does not provide a reading.No errors were reported.Device was then sent to nka for firmware update under a different record: (b)(4).Investigation summary: the root cause of reported issue was determined to be firmware related.An update is required to correct this issue.Capa 19-016 has been initiated.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
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Search Alerts/Recalls
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