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

Model Number 1009-9002-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyanosis (1798); Death (1802)

Event Date 04/13/2019

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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that after an open abdominal surgery for strangulated hernia, the patient, with multiple comorbidities, was extubated and became cyanotic.The patient was removed to the intensive care unit and later died.

Manufacturer Narrative

At the customer's request, ge healthcare service performed a checkout of the system after the reported event.The logs were reviewed and no errors were found.All checkouts and calibration testing passed.The system was returned to service ready for patient use.The unit remained in use for two days after the (b)(6) 2019 event without any reported issues.The customer requested a review of the system logs so ge healthcare product engineering performed an investigation of this event.An analysis of the system logs found no evidence of a system malfunction.Because there was no customer allegation of equipment defect or malfunction, the analysis of the system logs and review of the complaint confirm that the system did not cause or contribute to the patient's death.The root cause is undetermined.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8598804
• MDR Text Key: 144663102
• Report Number: 2112667-2019-00186
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K032803
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9002-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Weight: 76