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

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/22/2024

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.Legal manufacturer: hcs wuxi - no.19 changjiang road national hi-tech dev.Zone china wuxi jiangsu, 214028.

Event Description

The hospital reported a patient was connected to a carestation 650 when it was alleged that the unit stopped ventilating.It was reported that the patient became hypoxic for 5 minutes, and that the patient desaturated from 90% to 70%.Reportedly, the patient was switched to an ambu bag, and the unit was replaced during the case.There was no patient sequelae.Ge healthcare will submit a follow-up report when the investigation has been completed.

• 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: 19140069
• MDR Text Key: 340559865
• Report Number: 9710602-2024-00542
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682124560
• UDI-Public: (01)00840682124560(11)221214
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/18/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2022
• 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): Other