MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/28/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to an aespire 7100 when mechanical ventilation reportedly did not work.Reportedly, the patient desaturated.The patient was ventilated with an ambu bag and oxygen saturation was restored.The aespire 7100 was restarted and case resumed.Ge healthcare will submit a follow-up report when the investigation has been completed.

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.Hcs madison - 3030 ohmeda dr, usa madison, wi 53718.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Ge healthcare's (gehc) investigation has been completed.A third-party field engineer could not duplicate the event.No trouble shooting occurred and the device was placed back in use and there are no available logs for the reported event.The potential root cause includes an occlusion or leak within the unit, breathing system, or patient circuit that resolved itself.Gehc made several attempts to obtain additional details about the event, and based on the limited information received the root cause is undetermined.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 16673165
• MDR Text Key: 312597420
• Report Number: 9710602-2023-00328
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: 05/19/2023
• Date Device Manufactured: 12/24/2012
• 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
• Patient Age: 36 YR
• Patient Sex: Female