Model Number SERVO-U |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Type
Injury
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Event Description
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It was reported that during patient treatment in non-invasive nava mode of ventilation, an x-ray was performed and a pneumothorax was found.The pneumothorax required needle aspiration.The patient did not decompensate due to the pneumothorax.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).
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Manufacturer Narrative
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No service was requested by the user facility and no parts have been returned.It is unknown from which batch the edi catheter came from.According to the user facility, neither the ventilator nor the chosen ventilation mode caused the event of pneumothorax.It is believed that the patient was surfactant deficient which led to the pneumothorax.The patient is doing well and remain in the nicu for prematurity but are not in need of respiratory support.The root cause of the reported event was by the user facility determined as patient related.There are no indications of ventilator malfunction.H3 other text: 4117.
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Event Description
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Manufacturer's ref #: (b)(4).
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Search Alerts/Recalls
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