It was reported that while connected to the ventilator, the patient had elevated etco2 value.Once the expiratory bacterial filter was removed from the expiratory inlet of the ventilator, the value returned to normal.Patient's final outcome was no injury.Manufacturer's ref #: (b)(4).
|
No service was requested.The ventilator was examined by the user facility and no malfunctions were found.There was no recurrence of the reported issue when the expiratory bacterial filter was removed.The ventilator was returned for clinical use.No filter was returned for investigation and no ventilator logs were provided.According to information from the user facility, the problem was caused by a clogged expiratory bacterial filter from another brand.This results in an increased expiratory resistance, where the patient does not have time to breathe properly during the expiratory phase before a new breath is initiated.The user¿s manual contains a warning that when filter is used, user should carefully monitor the airway pressure.A clogged filter could result in increased airway pressure.Replace the filter if the expiratory resistance increases or after maximum usage time according to filter specification, whichever comes first.Length of use for the subjected filter is unknown.The conclusion is that the described error was caused by a clogged expiratory bacterial filter and not a ventilator malfunction.4117.
|