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

Model Number 1009-9050-000

Device Problem Increase in Pressure (1491)

Patient Problems Pneumothorax (2012); No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Customer contact reports no patient information available.Customer declined ge healthcare service.

Event Description

The hospital reported an over delivery of pressure in the patient circuit.There was no report of patient injury.

Manufacturer Narrative

Ge healthcare product engineering performed a root cause investigation of this event.Analysis of the returned valves found evidence of damage and grease contamination on the valve surfaces.The root cause of the positive end expiratory pressure (peep) rise above 30 cmh2o was determined to be a combination of scavenging misuse and contamination of the relief valve which stuck closed, since both conditions needed to occur in order for the observed pressure rise above 30 cmh2o as described.The root cause of the pneumothorax was likely a combination of scavenging system user error and contamination of the relief valve.

Manufacturer Narrative

Ge healthcareâ¿¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block b3 updated to (b)(6) 2020 from(b)(6) 2020.Block b5 updated with new information provided on 02/12/2020.Block h1 updated to serious injury.Block h3 updated to indicate investigation ongoing.Block h6 patient problem code updated to pneumothorax.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

Additional information was received reporting that on (b)(6) 2020, not (b)(6), during a direct laryngoscopy with biospy of a laryngeal lesion and trachestomy under general anesthesia, near the end of the procedure, the anesthesia machine failed to ventilate the patient.The bellows inflated but did not deflate.The next day ((b)(6) 2020), the hospital discovered that the patient had a pneumothorax (right lung collapsed).The hospital was unable to confirm if the malfunction of the machine, complications of the patient's health, or both resulted in the pneumothorax.

• 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: 9695973
• MDR Text Key: 192176682
• Report Number: 2112667-2020-00411
• 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,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9050-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 57