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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 02/08/2019

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 information: patient information could not be obtained due to country privacy laws.Reporter: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluated by mfr: device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that a patient undergoing a fibroscopy procedure de-saturated and after 15 minutes the patient had a cardiac arrest resulting in patient death.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.Ge healthcare product engineering performed an investigation of this event.A review of the logs showed that the system ventilated in automatic mode as normal with no issues reported.The patient was receiving oxygen initially through a mask connected to the auxiliary o2 port on the anesthesia machine.The auxiliary o2 will flow oxygen when the anesthesia machine is turned off so long as oxygen is being supplied to the anesthesia machine.In preparation for the procedure, the mask was removed, and the patient was connected to a breathing circuit attached to the anesthesia machineâ¿¿s inspiratory and expiratory ports.To control the o2 gas concentration and flow rate for the anesthesia machineâ¿¿s circle circuit, the operator must start a case.Per the complaint, the procedure was started at 13:55 hours.The patient desaturated.The patient was on his side during the exam and the medical staff noticed the condition of the patient when he was placed on his back.The patient then had a cardiac arrest and underwent heart fibrillation (cardiac massage).Oxygen flow did not begin until a second anesthetist put the patient on ventilation in automatic mode by pressing "start case now" beginning oxygen flow into the patient breathing circuit.The logs show the start case occurred at 14:05 hours.The root cause for the prolonged insufficient oxygen fresh gas flow into the patient breathing circuit was determined to be use error.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8427896
• MDR Text Key: 139045276
• Report Number: 2112667-2019-00020
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death