840 Ventilator

Description of Event or Problem

It was reported by the China Food and Drug Administration (CFDA), (b)(6) , and not reported directly to Medtronic by the customer that while in use on a patient, the (b)(4)ventilator's screen went black, the safety valve opened and gas delivery stopped resulting hypoxia to the patient. Manual ventilation with a resuscitation bag was immediately provided and the patient was removed from the ventilator and placed on an alternate ventilator without injury.

Additional Manufacturer Narrative

H3: Device Evaluation Summary Medtronic conducted an investigation based upon all information received. It was reported by the China Food and Drug Administration (CFDA),(b)(6) , and not reported directly to Medtronic by the customer that while in use on a patient, the (b)(4)ventilator's screen went black, the safety valve opened and gas delivery stopped resulting hypoxia to the patient. The ventilator was not made available to Medtronic for evaluation. The Third party service personnel had confirmed the reported issue and replaced power supply. The unit was reported to be working after part replacement. With the information available, the cause of the event was isolated to a potential fault in power supply. The event is included in a data monitoring plan. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.