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Model Number 8300 |
Device Problems
Device Sensing Problem (2917); Insufficient Information (3190)
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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 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.Although requested, further information was not provided.
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Event Description
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It was reported that the same etco2 error occurred in modules which are not included in the initial scope of the 8300 recall from august.The facility has identified at least 21 etco2 modules with the same issue (error codes 570.6200 and 570.6500), but with serial number/manufacturing dates that fall beyond the recall scope according to their bd contact.There was no report of patient incident or harm.Although requested, further information was not provided.
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Manufacturer Narrative
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The reported issue that the etco2 module had channel error, could not be confirmed; no product or device logs were returned for investigation.The device was not returned for investigation or repair.No failure data exists to review.Therefore, the proximate cause of the customer¿s reported issue cannot be determined.The reported event of device had etco2 channel error, was created to document the event that the customer reported.The customer did not return the device for evaluation.No device history search was performed since no source device serial number was reported by the customer.A review of the april 2021 complaint review board (crb) did not find an increasing trend for the reported issue of ¿etco2 channel error" based on the crb review and the limited information provided no further investigation actions will be performed.H3 other text : no product returned.
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Event Description
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It was reported that the same etco2 error occurred in modules which are not included in the initial scope of the 8300 recall from august.The facility has identified at least 21 etco2 modules with the same issue (error codes 570.6200 and 570.6500), but with serial number/manufacturing dates that fall beyond the recall scope according to their bd contact.There was no report of patient incident or harm.Although requested, further information was not provided.
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Search Alerts/Recalls
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