MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare (b)(6) investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Customer declined to provide patient information when requested.Unique device identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the patient experienced a cardiac arrest during the use of this device.The doctor reported that the patient recovered.

Manufacturer Narrative

Ge healthcare (gehc) product engineering performed an investigation of this event.A gehc salesperson was informed of this event by the customer.The customer would not provide any additional information.Based on manufacturing documentation, this device has an active adjustable scavenging system.It was discovered that the evacuation hose was not plugged into the scavenging system.Without the hose attached to the hospital's scavenging system, there would be no suction of scavenged gas from the machine.Depending on how open the adjustable needle valve was adjusted, some gas could escape from the machine, and any back pressure build-up above about 7.5cmh2o (with an upper limit of 10cmh2o) would be released by a pop-off valve.This maximum of 10cmh2o would manifest as positive end expiratory pressure (peep), and would be an unlikely cause of cardiac arrest.Failure to attach the scavenging hose was a mistake made by the user.Root cause is therefore user error.The gehc salesperson confirmed that the hospital does not allege any connection between the scavenging misuse and the cardiac arrest.The patient has since recovered.H3 other text : ge healthcare (gehc) product engineering performed an investigation of this event.A gehc salesperson was informed of this event by the customer.The customer would not provide any additional information.Based on manufacturing documentation, this device has an active adjustable scavenging system.It was discovered that the evacuation hose was not plugged into the scavenging system.Without the hose attached to the hospital's scavenging system, there would be no suction of scavenged gas from the machine.Depending on how open the adjustable needle valve was adjusted, some gas could escape from the machine, and any back pressure build-up above about 7.5cmh2o (with an upper limit of 10cmh2o) would be released by a pop-off valve.This maximum of 10cmh2o would manifest as positive end expiratory pressure (peep), and would be an unlikely cause of cardiac arrest.Failure to attach the scavenging hose was a mistake made by the user.Root cause is therefore user error.The gehc salesperson confirmed that the hospital does not allege any connection between the scavenging misuse and the cardiac arrest.The patient has since recovered.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9223963
• MDR Text Key: 219376926
• Report Number: 2112667-2019-01976
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1