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

Device Problems Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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 h3 other text : device evaluation anticipated, but not yet begun.

Event Description

It was reported that there was a malfunction resulting in loss of mechanical ventilation.There was no patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The anesthesia control board (acb) was replaced to resolve the issue.

• 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: 17883505
• MDR Text Key: 326026955
• Report Number: 9710602-2023-01049
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 11/02/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2017
• 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