G4: 29dec2020 b4: (b)(6) 2021.The device was in testing while being set-up for use.The customer had a standby ventilator which was immediately connected to patient and there was no delay in therapy.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The fse confirmed that the device was alarming low leak ¿ co2 rebreathing risk.The fse replaced the gas delivery system (gds) to resolve the issue and bring the device back to functionality.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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