MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 750; ANESTHESIA GAS MACHINE

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/20/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to a carestation 750 when it was alleged that the patient desaturated.Reportedly, fresh gas flow was increased to 15l, but the spo2 level dropped to 0% for 15-30 seconds.The patient was switched to manual ventilation and the patients spo2 level increased and the case was completed.There was no patient sequelae.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a1, a3, a4, a5, and a6: no information provided.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.

Manufacturer Narrative

Ge healthcares (gehc) investigation has been completed.Testing of the bottom breathing system found no issues.It is possible that after the clinicians moved the patient before beginning the procedure, accessory connections between the patient circuit and the patient mask got loose to cause a gas leak and contributed to the patient desaturation.The failure could not be reproduced on site and the root cause of the patient desaturation cannot be determined.

• Brand Name: CARESTATION 750
• 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: 18355330
• MDR Text Key: 330879698
• Report Number: 9710602-2023-01468
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K213867
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR