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

Device Problem Crack (1135)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

The hospital reported cracked bellows which would result 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 bellows 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: hcs (b)(4).

Manufacturer Narrative

Additional information was received stating that mechanical ventilation was working and available.There was not a reportable malfunction.H3 other text : additional information was received stating that mechanical ventilation was working and available.There was not a reportable malfunction.

• 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
• MDR Report Key: 13637111
• MDR Text Key: 289099884
• Report Number: 9710602-2022-00056
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 03/17/2022

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: 02/04/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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