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

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that they were unable to ventilate the patient in manual or mechanical mode with the device.The patient went into cardiac arrest.Chest compressions were provided to the patient and the patient was then reintubated with an endotracheal tube (et) tube.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system.The device was found to pass the full user checkout with no issues observed.Ge healthcare product engineering performed an investigation of this event.Engineering analysis of the system logs indicate several instances of sustained paw (positive airway pressure), ppeak high (high pressure), and apnea (cessation of breathing for 30 seconds or longer).Taken together, these alerts are most likely associated with a disconnect, leak, or blockage in the patient circuit caused by blockage in the breathing circuit, such as from a pinched or crushed segment of the expiratory circuit.It is unclear from the complaint data and system logs which actions the user took to resolve the issue.However, the system logs show the user changed from vent to bag mode multiple times, removed and reinserted the flow sensors multiple times, and removed and reinserted the gas module.None of these actions resolved the high pressure, and there is no evidence in the system logs that ventilation was successfully reestablished prior to ending the case.The root cause of the excessive pressure in the patient breathing circuit cannot be determined.Evidence points to the most likely cause as a stuck expiratory check valve.The root cause of the patient condition is undetermined given the information provided, as the patient was not on the device when the cardiac arrest occurred.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11271702
• MDR Text Key: 230017917
• Report Number: 2112667-2021-00307
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/19/2021; 03/03/2021; 04/30/2021
• Supplement Dates FDA Received: 03/04/2021; 03/12/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1