Model Number 8300 |
Device Problems
No Device Output (1435); Failure to Read Input Signal (1581); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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It was reported that the device failed preventive maintenance for the leak down test.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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The investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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It was reported that the device failed preventive maintenance for the leak down test.No additional information was provided.There was no patient involvement.
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Event Description
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It was reported that the device failed preventive maintenance for the leak down test.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they failed leak down test was confirmed due to a bad oridion board, replaced it a new oridion board.Performed leak down test and co2 calibration with passing results.A review of the device history record showed the device had a manufacture date of 19oct2018.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the proximate cause of the reported issue was due to bad etco2 oridion assy board v1 rohs.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
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Search Alerts/Recalls
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