MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. A4 ANESTHESIA MACHINE

Model Number 0630F-PA00001

Device Problem Gas Output Problem (1266)

Patient Problem Tachycardia (2095)

Event Type  malfunction  

Event Description

It was reported that the a4 anesthesia system was not working while in use on a patient, resulting in the patient rebreathing co2.The patient experienced a period of tachycardia but then returned to normal.

Manufacturer Narrative

An evaluation of the anesthesia machine was performed and the o2 cell cable was found to be loose causing a leak.The o2 cell cable was tightened and the system was tested and perfomred as designed.

• Brand Name: A4 ANESTHESIA MACHINE
• Type of Device: A4 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: serena chen ; 1203 nanhuan ave; guangming district; shenzhen, guangming 51810-6 ; CH 518106
• MDR Report Key: 15118139
• MDR Text Key: 303567149
• Report Number: 3009156722-2022-00014
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2022

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?: Yes
• Device Model Number: 0630F-PA00001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening