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Model Number 1006-9310-000 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 12/22/2021 |
Event Type
Injury
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Event Description
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Per medwatch report # mw5109273: "following intubation and prior to start of surgery in the ep lab, the ge aestiva anesthesia machine was unable to manually ventilate patient in the bag mode.Bag was distended but no chest rise observed when squeezed.Pt spo2 values decreased for period of 4 minutes, until machine was able to ventilate in mechanical ventilation mode.The intervention required to prevent permanent impairment/ damage at this point is that an ambu-bag had to be used to deliver oxygen to the pt.Next, the machine was reconnected to the pt, and successfully ventilated the pt.In mechanical ventilation mode.The other serious or important medical event was that the procedure was cancelled as a result of the desaturation event.Pt was not found to have sustained any neurological damage as a result of event, was discharged from hospital, and procedure was successfully performed 10 days later." ge healthcare will submit a follow-up report when the investigation has been completed.
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Manufacturer Narrative
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Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Ethnicity and race: information not available.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.
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Manufacturer Narrative
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The hospitalâs biomedical engineering staff found no evidence of device malfunction, and the device was returned to service after testing.The root cause of the loss of manual ventilation cannot be determined, though it is possible that a patient circuit occlusion contributed, and that the occlusion was resolved prior to ventilation with the ambu-bag or when the patient was reconnected to the aestiva mri and mechanical ventilation was resumed.The hospitalâs biomedical engineering staff found no evidence of device malfunction, and the device was returned to service after testing.The root cause of the loss of manual ventilation cannot be determined, though it is possible that a patient circuit occlusion contributed, and that the occlusion was resolved prior to ventilation with the ambu-bag or when the patient was reconnected to the aestiva mri and mechanical ventilation was resumed.
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Search Alerts/Recalls
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