MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problem Increase in Pressure (1491)

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

Event Date 06/26/2022

Event Type  malfunction  

Event Description

Per china aer database: it was reported that during patient use the anesthesia unit delivered high airway pressure and the manual ventilation is described as "not good".The patient was transferred to a different device and there was no report of patient harm.

Manufacturer Narrative

The unit was evaluated by on-site biomedical engineer and found the flow sensor is disabled and damaged.Further evaluation found the flapper of the flow sensor was stuck to the top of the flow sensor housing.The flow sensor was replaced to resolve the issue.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S.And therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).

• Brand Name: AESPIRE 7100
• 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: 15168741
• MDR Text Key: 302785833
• Report Number: 9710602-2022-00426
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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