Model Number 8300 |
Device Problem
Failure to Read Input Signal (1581)
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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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The affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
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Event Description
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It was reported that the device failed leak down test.There was no patient involvement.
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Event Description
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It was reported that the device failed leak down test.There was no patient involvement.
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Manufacturer Narrative
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The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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It was reported that the device failed leak down test.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 failed leak down test was confirmed due to bad oridion board.Replaced it with a new oridion board.Performed leak down test and co2 calibration with passing results.A review of the device history record for (b)(6) was performed, which showed the device had a manufacture date of 22oct2018 and confirmed that this device was not involved in a production failure which correlates to the customer reported issue.The review was performed from the date of manufacture to the date of product release for distribution.A review of the complaint history record was performed for the (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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