MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

Model Number 1006-9305-000

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Respiratory Arrest (4461)

Event Date 02/12/2021

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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the inspiratory flow sensor flapper valve stuck closed, preventing oxygen flow to the patient while the device was in manual ventilation mode.Cpr was administered and the patient was transported via ambulance to nearby hospital for evaluation.The patient was later discharged with no apparent injuries/concerns.

Manufacturer Narrative

Ge healthcare (gehc) product engineering performed an investigation of this event.The complaint alleged that the inspiratory flow sensor (ifs) was stuck closed.The ifs was stuck open in the body of the sensor, (i.E.Not in the direction of flow for an ifs).The most likely cause for an ifs flap to be stuck open is the mechanical insertion of an object.Flow provided by the anesthesia machine under normal conditions will not cause the flapper to become stuck open.The anesthesia machine was in bag mode during the time of the alleged incident as the clinician reports adjusting the adjustable pressure limit (apl) valve to free the flapper쳌.The ifs shows no signs of anything abnormal that could have caused an obstruction and by design there is nothing that can be stuck closed since the flapper has clearance around the entire perimeter.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11502992
• MDR Text Key: 240293263
• Report Number: 2112667-2021-00741
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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
• Device Model Number: 1006-9305-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 79