The manufacturer previously reported a patient was found removed from his mask and the ventilator was allegedly turned off.Cardiopulmonary resusitation was performed.The patient expired.The ventilator's downloaded event logs were reviewed by the manufacturer and the manufacturer concludes the ventilator did not cause or contribute to the reported event.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.The device is not returning to the manufacturer for evaluation.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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