Model Number 0620040600 |
Device Problems
Increase in Pressure (1491); Pressure Problem (3012)
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Patient Problems
Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that patient had suffered a collapsed lung due to overpressure.
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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 patient had suffered a collapsed lung due to overpressure.
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Manufacturer Narrative
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Alleged failure: (b)(4), biomed, the pressure is fluctuating dramatically and not consistent, po # (b)(4).Update: the statement made to me on the phone was "the pressure shot up to 21, so high that it collapsed the patients lungs".They then put the unit in pediatric mode and have no further issues.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be an incorrect orientation of the o-ring on the tubeset adapter and/or the venting system being off which would cause the overpressure to not be relieved.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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Search Alerts/Recalls
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