Model Number FM300 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 10/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the patient experienced high co2 levels and crepitus.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: excessive co2 in the blood probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that the patient experienced high co2 levels and crepitus.
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Search Alerts/Recalls
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