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

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 03/18/2022

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.Questionnaire requesting patient information was sent to the end user on 04/11/2021 and 04/13/2021.No patient information provided to date.(b)(4).Legal manufacturer: hcs (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the patient coded during a case.Ge healthcare's investigation into the reported occurrence is ongoing.

Manufacturer Narrative

The cause of the reported event is undetermined.The customer reported the unit has been returned to use, no malfunction was confirmed, and hospital has declined multiple attempts to provide further information to ge healthcare.The cause of the reported event is undetermined.The customer reported the unit has been returned to use, no malfunction was confirmed, and hospital has declined multiple attempts to provide further information to ge healthcare.

• 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: 14119517
• MDR Text Key: 289348118
• Report Number: 2112667-2022-00879
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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?: No
• 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: 03/18/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/26/2022
• Date Device Manufactured: 09/24/2020
• 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