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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2022

Event Type  malfunction  

Event Description

The hospital reported a malfunction resulting in light anesthesia causing the patient to move during the procedure.There was no report of patient injury or patient recall.

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information provided to date.Unique identifier: (b)(4).Legal manufacturer: (b)(4).

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.Block a: no patient information provided after calls to customer (b)(6) 23 and (b)(6) 23.

• 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
• MDR Report Key: 16216889
• MDR Text Key: 308446457
• Report Number: 2112667-2023-00284
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• 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: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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