Model Number 0620040600 |
Device Problems
Increase in Pressure (1491); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Electrolyte Imbalance (2196); Low Oxygen Saturation (2477); Chemical Exposure (2570)
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Event Date 09/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the patient experienced excessive co2 levels.
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Manufacturer Narrative
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Alleged failure: hard time reading pressure accurately/ may have over pressured.Rep thinks adapter may have issues as well.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The root cause is a missing o-ring on the tubeset adapter which was connected to the complaint unit.The missing o-ring can cause pressure and flow fluctuations.The product was returned for investigation and the 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 excessive co2 levels.
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Search Alerts/Recalls
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