MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY A5 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	A5
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mindray service representative reported that bellows appear to be floppy/stretched.Service representative did not notice check valve sticking.No photo are available.Part has been discarded.Service representative noticed that the bellows would never completely fill up it always had a slouch to it and was caved in a little on one side.Logs were collected and it is under investigation.
Event or Problem Description
It was reported that during first use of their machine after a preventive maintenance, when ventilating a patient, the a5 produced a continuous airway pressure alarm and would not ventilate properly.No patient injury was reported.
Additional Manufacturer Narrative
Following the occurrence, the service team was consulted.It was determined that preventive maintenance had been performed on the anesthesia machine in early june 2025.During this maintenance, the pop-off valve within the respiratory system was disassembled and subsequently reassembled.Based on logs evaluation and the data collected the investigation suggests that the likely root cause of the alarm was improper installation of the pop-off valve during maintenance, which resulted in deformation of the valve's diaphragm.The deformed diaphragm of the pop-off valve was replaced on june 13, 2025.Post-replacement, the anesthesia machine has been monitored and, as of july 1, 2025, the issue has not recurred.The service representative was retrained to ensure future proper installation of the pop-off valve.
Event or Problem Description
It was reported that during first use of their machine after a preventive maintenance, when ventilating a patient, the a5 produced a continuous airway pressure alarm and would not ventilate properly.No patient injury was reported.

• Brand Name: MINDRAY A5 ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: anna jeczen ; 800 macarthur blvd; mahwah, NJ 07430-2225 ; 2019958096
• MDR Report Key: 22435985
• Report Number: 3009156722-2025-00011
• Device Sequence Number: 4708766
• Product Code: BSZ
• UDI-Device Identifier: 06944904030272
• UDI-Public: 06944904030272
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K171311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Model Number: A5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown