It was reported that the patient was using a bivona® 8.0mm aire-cuf tracheostomy tube and the pilot balloon was over inflating on one side and causing some trouble a with ventilation on a home bound trached patient.The fault was discovered while testing the cuff patency prior to use with air by the spouse/caregiver/nurse as well as respiratory therapist.Significant ventilation issues were noticed 7-10 days prior to death, the patient was ultimately unresponsive to tracheostomy changes and deep suctioning.It was also reported that these events happened on 3 tracheostomy tubes and the last "live" download was on (b)(6) 2017, indicating high pip (peak inspiratory pressure) alarm started to frequently develop about 10 days prior to death.The patient was switched back to a different manufacture tracheostomy tube on (b)(6) 2017, before the time of sudden death.It was reported that the assumed death was due to cardiac arrest not an airway issue.
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