MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY GE HEALTHCARE AESTIVA ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Model Number AESTIVA/5 MRI

Device Problem Energy Output Problem (1431)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/22/2021

Event Type  Injury  

Event Description

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.Fda safety report id# (b)(4).

• Brand Name: GE HEALTHCARE AESTIVA ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY
• MDR Report Key: 14188063
• MDR Text Key: 290002303
• Report Number: MW5109273
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AESTIVA/5 MRI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male