MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620; ANESTHESIA GAS MACHINE

Device Problem Inaccurate Delivery (2339)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The link-25 system was re-installed and calibrated to resolve the issue.Block a: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

It was reported that there was a malfunction that could cause a hypoxic mixture in the patient circuit.There was no report of patient involvement.

• Brand Name: CARESTATION 620
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18874740
• MDR Text Key: 337327738
• Report Number: 9710602-2024-00336
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682103985
• UDI-Public: 01008406821039854
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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