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

Device Problem Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/22/2021

Event Type  Injury  

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 could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported the unit shut down during a case, resulting in a loss of mechanical ventilation.The patient was switched to manual ventilation mask but the clinician was unable to provide oxygen through the o2 connection of the ventilator.The clinician retrieved an o2 rotameter to resume ventilation with room air.Reportedly, when the patient's sedation started to weaken, ventilation became more difficult and then stopped, resulting in desaturation to 68% for one minute.After removal of the larynx mask, manual ventilation was then resumed with another device, and iv sedation resumed.Surgery was discontinued.The hospital reported no patient harm.

Manufacturer Narrative

Based on the information provided in the complaint and device logs, the cause of the blank screen was determined to be a poor connection in the ribbon cable to lcd, which is internal to the display unit.The connection was cleaned and reconnected to resolve the issue.It was determined that the clinician did not properly utilize the device backup and safety features in response to the malfunction.The actions taken by the clinician to remove the patient from the ventilator and not have backup ventilation available resulted in the patient desaturation.

• Brand Name: AVANCE
• 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: 12565172
• MDR Text Key: 274453705
• Report Number: 2112667-2021-02236
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/01/2022

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?: 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
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2003
• 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): Required Intervention