Model Number 8300 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, the affected device has not been received.A follow up report will be submitted with 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 had communication error.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 had communication error.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Manufacturer Narrative
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The reported issue was confirmed.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they communication error was confirmed due to corrupted data, flashed s/w 9.33 passed.Also both iui connectors worn out for their wear, replaced two new iui connectors.Performed leak down test and co2 calibration with passing results.Based on the findings, service determined that the probable cause of the reported issue was due to corrupted data of the software.A review of the device history record showed the device had a manufacture date of 15mar2018.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed, which did not confirm similar complaints with the same or related failure mode for this customer.
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Event Description
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It was reported that the device had communication error.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 had communication error.No additional information was provided.There was no patient involvement.
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Search Alerts/Recalls
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