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

Model Number A5 ANESTHESIA MACINE

Device Problem Gas/Air Leak (2946)

Patient Problem Loss of consciousness (2418)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

An investigation is in process.

Event Description

It was reported that during a case where a patient was being monitored on an a5 anesthesia system, three (3) hospital personnel got sick in the room due to a vaporizer leak.2 of the 3 personnel did not need medical intervention but the 3rd passed out, fell on the floor and needed medical assistance.The case was completed without consequences for the patient or the doctor performing the procedure.

• Brand Name: A5 ANESTHESIA SYSTEM
• Type of Device: A5 ANESTHESIA
• 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: 15289785
• MDR Text Key: 298560984
• Report Number: 3009156722-2022-00018
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/26/2022

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: A5 ANESTHESIA MACINE
• Device Catalogue Number: 0631F-01000-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other