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

Model Number 1012-9650-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

Gehca's fe performed a checkout of the carestation 650 but could not confirm the reported issue.The device was returned to service.Gehca'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.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

The hospital reported a patient was connected to a carestation 650 when it was alleged that the patient desaturated.The unit was switched from auto mode to bag mode near the end of the case, when it was noticed that tidal volume was about 100ml/m which did not match the unit settings.The patient's vitals continued to drop, so it was decided to bag the patient manually.There was no patient sequelae.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

The failure could not be reproduced on site and no further information was provided by the end user after multiple attempts, therefore the root cause of this incident could not 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: 17970099
• MDR Text Key: 326119538
• Report Number: 2112667-2023-05473
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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