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

Model Number 1009-9212-000

Device Problem Pressure Problem (3012)

Patient Problem Cardiac Arrest (1762)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Patient identifier information could not be obtained.Unique device identifier: (b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

'the hospital reported a patient had cardiac arrest during a case.It was alleged the ventilator had stopped mechanically ventilating in pressure mode towards the end of the case without alarming.It was unknown how long ventilation had stopped.The patient was resuscitated and remains in the icu.

Manufacturer Narrative

Ge healthcare (gehc) product engineering performed an investigation of this event.The root cause of this event is undetermined and could not be reproduced.A gehc service representative performed a checkout of the equipment and was not able to confirm the reported complaint.The alarm logs showed 8 instances of â¿¿vol vent only".No positive end expiratory pressure (peep) or "pressure support ventilation" (psv) alarm during boot cycle 979.The sensor interface board (sib) would be the only cause of this alarm.The sib was tested in the laboratory and the board did not show any signs of failure during use.The sib was replaced proactively and the unit was returned to service.The patient was resuscitated and moved to the intensive care unit.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8319602
• MDR Text Key: 135493208
• Report Number: 2112667-2019-00011
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K092864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 1009-9212-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 70