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

Device Problem Gas/Air Leak (2946)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

The hospital reported a leak resulting in inaccurate tidal volume.There was no patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The breathing circuit was replaced to resolve the issue.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Legal manufacturer: (b)(6).

Manufacturer Narrative

Additional information was received stating that the leak rate was less than 4.5l/min.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.There was not a reportable malfunction.H3 other text: additional information was received stating that the leak rate was less than 4.5l/min.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.There was not a reportable malfunction.

• 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: 13342813
• MDR Text Key: 289020428
• Report Number: 2112667-2022-00157
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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