The hospital reported that while in use on a patient, the system alarmed and subsequently shut down resulting in a loss of mechanical ventilation.The hospital also reported that after this event, the patient died from causes not related to the ge healthcare ventilator.
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After the event, a ge healthcare field engineer evaluated the system and system logs.A system checkout was performed.The circuit leak test failed.The exhalation housing was leaking.The exhalation housing was replaced.The checkout was performed again and passed.Per engineering recommendation, the ventilator control board (vcb) was replaced.The original vcb was returned to ge healthcare product engineering for evaluation.Ge healthcare product engineering performed an investigation of this event.The returned vcb was installed into another unit for testing.The ventilator ran for a week and the reported shutdown could not be duplicated.The system logs were also reviewed, and it was concluded that the device did not malfunction while the patient was on the ventilator, but did shut down after the patient was removed from the ventilator.The root cause of the reported issue is undetermined because the issue could not be duplicated.The customer respiratory therapy manager stated that the patient died a day or two later but not due to the ventilator issue.Therefore, the ventilator did not cause harm to the patient or contribute in the patient's death in the days following the incident.
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