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

Model Number 1011-9000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 03/29/2019

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 id and patient weight unavailable.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a patient death during a complex wound procedure being performed on a (b)(6) year old obese female paraplegic patient with multiple comorbidities in the prone position.There is no allegation of anesthesia machine malfunction at this time.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation of this event.A ge healthcare service representative retrieved the logs for the time this event occurred (b)(6) 2019 at 12:00:00), as requested by the customer for an internal investigation.The logs show the final day of use before the logs were obtained was b)(6) 2019.Review of the device logs for the second and final case on 29-mar-2019 did not reveal any resets or stoppages of the device.At 1:15 pm the device reported a positive end expiratory pressure (peep) pressure control ventilation (pcv) not available alarm which cleared after three minutes.The device was in volume control ventilation (vcv) at the time of the alarm, so ventilation was not lost.The alarm activation and deactivation is highlighted in the logs.The user continued to ventilate with the device for an hour until the end of the case.Parameter alarms were present throughout the case but there is no indication of a device malfunction causing or contributing to their presence.The customer has made no allegation of failure against the system.A root cause cannot be established as there was no allegation of fault against the device.Because there is no allegation of failure and there is no evidence of system malfunction, it is determined that the device did not cause or contribute to the patient demise.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8560166
• MDR Text Key: 143393733
• Report Number: 2112667-2019-00182
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• 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: 06/06/2019

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: 1011-9000-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR