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

Model Number 1009-9012-000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Death (1802); Brain Injury (2219)

Event Date 03/24/2019

Event Type  Death  

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 weight information unavailable.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported an alleged failure of the system resulting in excess co2, leading to brain injury during procedure and eventual patient death.

Manufacturer Narrative

After the reported event, a ge healthcare service representative performed a checkout of the system but did not find any issue with the system.The system performed as expected and was returned to service.Also, ge healthcare engineering performed an investigation of the reported event.The customer reported that the system did not malfunction during the case, but that past co2 reading errors (described as "unorganized co2 wave form or false low reading") on the gas module led the team to fail to respond appropriately to the "line occluded" message on the gas module in a timely manner, leading to an anoxic brain injury.The aespire 7900 is separate from the gas module, but readings from the gas module are used to inform users of settings and setup changes that should be made on the aespire 7900.Review of complaint data indicates no malfunction of the aespire 7900 system that could cause or contribute to a patient's death.The root cause is undetermined.

• Brand Name: AESPIRE 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8582628
• MDR Text Key: 144147284
• Report Number: 2112667-2019-00184
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K050626
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1009-9012-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR