Model Number 8300 |
Device Problems
Failure to Read Input Signal (1581); Pressure Problem (3012)
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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 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 had failed co2 sensor accuracy test.No patient involvement.
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Manufacturer Narrative
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The customer reported problem was confirmed.A review of the device history record for sn(b)(6) was performed from date of manufacture 08/17/2017 to present date 01/18/2021 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.
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Event Description
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It was reported that the device had failed co2 sensor accuracy test.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 reinstalled tubing for failed co2 sensor accuracy test.Replaced contaminated left iui.A review of the device history record for sn (b)(6) was performed from date of manufacture (b)(6) 2017 to present date (b)(6) 2021 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.Based on the findings, service determined that the proximate cause of the reported issue was due to failed co2 sensor accuracy test (tubing pinched) - reinstalled.The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.There are capa #'s noted for the following parts replaced that have an already existing capa.Capa# (b)(4) iui conn issues.
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Event Description
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It was reported that the device had failed co2 sensor accuracy test.No patient involvement.
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Search Alerts/Recalls
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