Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.
|
Ge healthcare (gehc) product engineering performed an investigation of this event.Device logs show the case began at 12:51 pm.Pre-use checkout of the unit was not performed.During the case there were no logged events that would indicate a device fault or failure.The logs show that the clinician(s) may have had trouble ventilating the patient.The device was switched between bag and mechanical ventilation modes several times.The o2 flush button was also used repeatedly for part of the case, several times for more than 30 seconds continuously.The device logs show one occurrence of patient circuit leak occurring at 1:19 pm.At 1:58 pm the device received low o2 pressure, and drive gas lost and o2 pressure low alarms were present.The condition ended after 85 seconds.After 20 minutes with no alarms, at 2:20 pm, the clinician switched to bag mode.The machine then alarmed for co2 apnea several times over the next ten minutes.Twice the apnea lasted at least two minutes.Another period with no alarms lasted from 2:31 pm to 2:41 pm.At 2:41 pm many occurrences of high expir tv occurred until the end of the case.From 3:07 pm until 4:01 pm there were also occurrences of the subatmospheric airway pressure alarm, usually lasting one or two seconds each.The case was ended at 4:19 pm, but it is unknown at what time the patient died.H3 other text : ge healthcare (gehc) product engineering performed an investigation of this event.Device logs show the case began at 12:51 pm.Pre-use checkout of the unit was not performed.During the case there were no logged events that would indicate a device fault or failure.The logs show that the clinician(s) may have had trouble ventilating the patient.The device was switched between bag and mechanical ventilation modes several times.The o2 flush button was also used repeatedly for part of the case, several times for more than 30 seconds continuously.The device logs show one occurrence of patient circuit leak occurring at 1:19 pm.At 1:58 pm the device received low o2 pressure, and drive gas lost and o2 pressure low alarms were present.The condition ended after 85 seconds.After 20 minutes with no alarms, at 2:20 pm, the clinician switched to bag mode.The machine then alarmed for co2 apnea several times over the next ten minutes.Twice the apnea lasted at least two minutes.Another period with no alarms lasted from 2:31 pm to 2:41 pm.At 2:41 pm many occurrences of high expir tv occurred until the end of the case.From 3:07 pm until 4:01 pm there were also occurrences of the subatmospheric airway pressure alarm, usually lasting one or two seconds each.The case was ended at 4:19 pm, but it is unknown at what time the patient died.
|