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

Device Problem No Flow (2991)

Patient Problems Death (1802); Hypoxia (1918)

Event Date 01/24/2020

Event Type  Death  

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

Ge healthcare was notified that, during knee surgery, there was no fresh gas flow coming from the patient y-connector both in bag and vent mode and pressure inside the bag was not released even when the patient y-connector is open, resulting in patient hypoxic arrest and subsequent patient death.

Manufacturer Narrative

A ge healthcare (gehc) field engineer (fe) performed a checkout of the system and did not confirm the reported issue.Gehc product engineering performed a root cause investigation of this event.Gehc engineering received and reviewed the service logs pulled from the device as well as pictures taken of the inspiratory flow check valve.Based on the customer observations of taut bag, no flow, lack of alarms other than negative pressure in the patient circuit, as well as the audible "pop"쳌 heard as gas flow began, potential root causes were narrowed to the inspiratory check valve stuck fully closed.The inspiratory check valve was replaced by the gehc fe.The root cause of the lack of flow cannot be determined due to the inability to reproduce the issue or have the suspected part returned for further analysis.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 9726632
• MDR Text Key: 179958993
• Report Number: 2112667-2020-00452
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 YR