MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650; ANESTHESIA GAS MACHINE

Model Number 1012-9650-000

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/26/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to a carestation 650 when it was alleged that the patient spo2 level dropped to 60% during manual ventilation.The patient was switched to manual ventilation with an ambu bag and supplemental o2.Spo2 levels recovered, and the patient was reconnected to the carestation 650 and manual ventilation attempted.The patient desaturated to 80% and the patient was again switch to manual ventilation with an ambu bag.Spo2 levels recovered, the patient was reconnected to the carestation 650 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 healthcare's (gehc) fe performed a checkout of the carestation 650 but could not confirm the reported issue.Gehc's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: no patient information provided to date.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Manufacturer Narrative

Ge healthcare' s (gehc) investigation has been completed.The gehc's field engineer completed a review of the system logs and checkout of the device.The root cause of the alleged loss of ventilation cannot be determined.

• Brand Name: CARESTATION 650
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18187463
• MDR Text Key: 328735943
• Report Number: 2112667-2023-06206
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1012-9650-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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