The manufacturer received information alleging a ventilator failed to alarm when a circuit disconnect occurred and the patient required cardiopulmonary resuscitation in response to the alleged event.The device was returned to the manufacturer's product investigation laboratory for investigation.The ventilator's downloaded event logs were reviewed by the manufacturer and the manufacturer confirmed that the device did alarm appropriately on the date of the alleged incident to alert the caregiver of multiple circuit disconnect conditions.The device was tested and found to operate within specifications and volume requirements.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 manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.
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