MAUDE Adverse Event Report: GE HEALTHCARE ADVANCE CS2; GAS - MACHINE, ANESTHESIA

Model Number AVANCE CS2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 12/05/2019

Event Type  Injury  

Event Description

Anesthesia machine failed it "full test" due to not holding circuit pressure.The circuit was completely changed out.Full test was tried again and the machine failed the test.The circuit was changed out again and the cover flow sensors were checked.The machine failed its third "full test." the circuit was completely changed out as well as the pt tube, the co2 absorber, the o2 line was plugged directly into the port (instead of through the oxygen fitting), and the cover flow sensor.The machine then passed its "full test".The pt was brought into the operating room, and the operation started.The machine held continuous peep above 20, despite having a flat scavenger bag and decreasing the tidal pressure.For pt safety the operation stopped and the pt was awakened.Anesthesia machine was taken out of service.The biomet staff was called and they serviced the machine on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: ADVANCE CS2
• Type of Device: GAS - MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 9525952
• MDR Text Key: 173235320
• Report Number: MW5091914
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVANCE CS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 126