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

Device Problem Insufficient Information (3190)

Patient Problem Asystole (4442)

Event Date 10/04/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to a carestation 650 when it was alleged that the patient experienced bradycardia and subsequent asystole.The clinician noted the unit was ventilating correctly but the bellows of the device and the patient's thorax were not moving.The patient was switched to manual ventilation and the patient was resuscitated and regained spontaneous circulation.The clinicians attempted auto mode ventilation again, and the same issue recurred.The patient was switched back to manual ventilation and the case was canceled.The patient was transferred to icu and the patient recovered.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare's (gehc) fe performed a checkout of the carestation 650 but could not duplicate the reported issue.Gehcs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.A5 and a6: information not available.D4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Manufacturer Narrative

Ge healthcare investigation with the end user determined the root cause was the patient pneumothorax.There was no device malfunction that contributed to the reported event.Site risk management team agreed.H3 other text: ge healthcare investigation with the end user determined the root cause was the patient pneumothorax.There was no device malfunction that contributed to the reported event.Site risk management team agreed.

• 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: 18055043
• MDR Text Key: 327154388
• Report Number: 9710602-2023-01205
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: 10/04/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 110 KG