MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650; ANESTHESIA GAS MACHINE

Device Problems Insufficient Flow or Under Infusion (2182); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  malfunction  

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.Block a: patient information could not be obtained due to country privacy laws.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718 h3 other text : device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a malfunction resulting loss of delivery of anesthesia and causing the patient to wake up during the procedure.There was no patient recall, no patient injury.

Manufacturer Narrative

Ge healthcare as (gehc) investigation has been completed.The gehc as field engineer inspection of the device and the device logs found no evidence of a malfunction.The end user did not provide enough gas flow to the patient, used a non-gehc vaporizer, and did not properly seat the vaporizer.Therefore, the root cause is use error.

Event Description

The hospital reported a patient was awake during a procedure while connected to a carestation 650.Reportedly, the anesthetist noticed that the vaporizer was delivering less sevoflurane than what had been dialed up.The anesthetist then reseated the vaporizer, and the inspired sevoflurane level started to rise.The remaining period of surgery was uneventful.Allegedly, the patient requested psychiatric treatment 3 days after the surgery.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.

• Brand Name: CARESTATION 650
• 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: 18395862
• MDR Text Key: 331675504
• Report Number: 9710602-2023-01497
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151570
• 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,Followup
• Report Date: 03/05/2024

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: 11/27/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/31/2024; 03/01/2024
• Supplement Dates FDA Received: 02/15/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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