G4: 02mar2021.B4: 02mar2021.The v680 is an exported device and not available for commercial distribution in the united states, therefore does not fall within fda reporting guidelines.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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G4: (b)(6) 2021, b4: (b)(6) 2021.The hospital's biomedical engineer evaluated the device.The customer requested a review of the diagnostic report along with the philips remote service engineer (rse).There was no request for a philips field service engineer (fse) onsite visit.Review of the provided photographs of the diagnostic report showed that the hospital staff cancelled the device¿s self-test (501f) prior to initiating therapy, and multiple low minute ventilation (120e), high inhalation pressure (1206), and high positive end expiratory pressure (121a) alarms were generated throughout the event.No error codes were reported.No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.H10/h11 this reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with an admitting diagnosis of acute respiratory distress syndrome.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient underwent placement of a 7.5 millimeter endotracheal tube; brand and model not reported.While admitted on (b)(6) 2020, the patient was prescribed synchronized intermittent mandatory ventilation, volume controlled ventilation (simv-vcv) via the respironics v680 ventilator; tidal volume 450 milliliters, respiratory rate 16 breaths per minute, and fraction of inspired oxygen (fio2) 40%.The patient circuit, and patient interface were not reported.While admitted on (b)(6) 2020 at approximately 0100, the patient was receiving therapy from the v680, the hospital staff cancelled the v680¿s self-test (501f) at 01:00.02 am, at 01:00.27 am 100% fio2 was administered to the patient, and multiple low minute ventilation (120e), high inhalation pressure (1206), and high positive end expiratory pressure (121a) alarms were generated throughout the event.At a time not reported later on (b)(6) 2020, the patient experienced an outcome of death.No relevant laboratory data was reported.Neither the primary nor secondary cause of death was reported.There is no information to support that a malfunction occurred.However, hospital staff cancelled the device¿s self-test (501f) prior to initiating therapy.It is recommended that users run extended self-test and short self-test as required, before placing the ventilator on a patient (respironics v680 ventilator, user manual, publication number 1099909, revision e, (b)(6) 2019, page 11).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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