MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE

Device Problem Unexpected Shutdown (4019)

Patient Problem Cardiac Arrest (1762)

Event Date 04/04/2022

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.Ethnicity and race not available.Unique identifier: (b)(4).Legal manufacturer: (b)(4).

Event Description

The hospital reported a patient death after use of the avance cs2.It was reported that the unit stopped ventilation during the case.The anesthesiologist proceeded to use an oxygen cylinder and a non-ge healthcare patient circuit, and performed cpr for 6 minutes.The patient was transferred to intensive care in critical condition.The following day, the patient reportedly presented arrhythmias and cardiac arrest and died.Ge healthcare's investigation into the reported occurrence is ongoing.

Manufacturer Narrative

The root cause is the hospital had used an unapproved power supply, further modified it creating intermittent ac power losses, which likely caused the frequent losses of ac power.There were no repairs to the anesthesia machines ac power components as only the non-ge external power strip required correction.While the ge field engineer was on site evaluating the device, they identified that the customer was using an unapproved non-medical power strip to provide ac mains power to the anesthesia machine.During their inspection of the anesthesia machine, the power strip unexpectedly turned off without any switch being selected.Further review of the power strip identified that it had been modified from its original commercial condition to directly connect to an isolated panel.The modifications of the power strip caused poor and faulty contact which interrupted the power causing the anesthesia machine to run on battery.Because there were many alarms, over multiple weeks, the device's logs only contained approximately 50 days of data as the logs had begun to overwrite the earliest data.Over the approximately 7 weeks, the logs identified 109 ac power losses.It is likely that the power strip was causing intermittent losses of power, leading to the anesthesia machine's 109 ac mains power interruptions, thereby causing irregular and inadequate charging cycles.Over 7 weeks of failures, there were multiple full depletions of a battery for too long, as well as inadequate/incomplete charge cycle times, which caused undue stress to the battery leading to a shortened battery life.(continued in block h11).

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 14305696
• MDR Text Key: 290902658
• Report Number: 2112667-2022-01139
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 7 KG