Model Number GF-210RA |
Device Problems
Gas Output Problem (1266); Unable to Obtain Readings (1516); 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 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the multigas unit (gf-210ra) failed during use.No consequence or impact to the patient.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that the multigas unit (gf-210ra) failed during use.No consequence or impact to the patient.
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Event Description
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The customer reported that the multigas unit (gf-210ra) failed during use.No consequence or impact to the patient.
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Manufacturer Narrative
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Details of complaint: the customer reported the multigas unit was not working.The customer sent the device in for exchange.No patient harm was reported.Service requested / performed: exchange / evaluation: exchange / evaluation: nka's repair center evaluated the device on (b)(6) 2020.The reported issue could not be duplicated.A double-check was performed on (b)(6) 2020.No problems were found.The multigas device performance is dependent upon the appropriate connection of the air tubes, connectors, and watertrap.Since the exact setup could not be replicated in the laboratory environment, the root cause of the reported issue could not be confirmed or determined.No issues found with the unit.Investigation summary: the overall risk score is medium.The root cause of the reported issue could not be determined.Based on sop07-003, no capa is required as the quality event does not warrant a corrective action.
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Search Alerts/Recalls
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