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

Model Number 0631B-PA00021

Device Problem No Apparent Adverse Event (3189)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/25/2022

Event Type  Death  

Event Description

It was reported that on (b)(6) 2022 a patient expired while being monitored on a mindray a5 canadian anesthesia machine.

Manufacturer Narrative

Logs from the anesthesia system were evaluated.During the time of the reported event several "o2 supply failure" alarms were triggered.The o2 supply was correctly monitored by the anesthesia system with corresponding alarm notifications.No device malfunction was confirmed.Preventive maintenance was performed on the anesthesia system, which passed all tests.

• Brand Name: A5 CANADIAN ANESTHESIA MACHINE
• Type of Device: A5 ANESTHESIA MACHINE
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.; 1203 nanhuan ave; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.; 1203 nanhuan ave; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: patrice martinez ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958026
• MDR Report Key: 16042492
• MDR Text Key: 306074638
• Report Number: 3009156722-2022-00021
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0631B-PA00021
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death