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

Device Problem Pressure Problem (3012)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The vaporizer ports were cleaned and reseated to resolve the issue.Block a: no report of patient involvement.Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

It was reported that there was a malfunction resulting in loss of pressure during manual ventilation.There was no 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 ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18126581
• MDR Text Key: 328002379
• Report Number: 2112667-2023-05978
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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