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

Device Problem Defective Alarm (1014)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information provided to date.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a patient was connected to an avance when the unit did not alarm when the patient's spo2 dropped below 50%.There was no patient injury.

Manufacturer Narrative

The complaint for the unit not alarming when the patient's spo2 dropped below 50% is applicable only to the patient monitor that was in use.The avance does not measure, and therefore does not alarm for, blood oxygen levels (spo2).The avance has the capability to measure fraction inspired and fraction expired values for o2, co2, and agent.These values would only lead to an alarm based on the alarm limits set by the clinician.There was no allegation related to avance alarms or performance from the event.The ge healthcare fe inspected the anesthesia machine and found no issue.The patient monitor was inspected.The service personnel found that the alarms had been turned off.The staff was informed of what they found.The monitor was tested and no other issues were identified with respect to the alarm system.On follow-up, the customer acknowledged that the issue was due to user error and did not want any further investigation into it by ge healthcare.

• 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: 16689117
• MDR Text Key: 312772601
• Report Number: 2112667-2023-01844
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/09/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2009
• 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