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  Injury  

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 performed as designed.

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.

• 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
• MDR Report Key: 15118146
• MDR Text Key: 296751961
• Report Number: 2221819-2022-00014
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022,06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0630F-PA00001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening