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

Model Number 1012-9650-000

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Absorbent canister was replaced by the customer.There was no ge service.Customer contact reports no patient information is available.Unique identifier: (b)(4).Legal manufacturer: (b)(6).Absorbent canister was replaced by the customer.There was no ge service.Customer contact reports no patient information is available.Unique identifier: (b)(4).Legal manufacturer: (b)(6.

Event Description

The hospital reported a malfunction causing a leak greater than 4.5lpm.There was no report of patient involvement.

• 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: 14620851
• MDR Text Key: 293534589
• Report Number: 2112667-2022-01431
• 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
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Date Device Manufactured: 12/14/2017
• 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