MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD GAS MODULE 3

Catalog Number 0998-00-1900-01

Device Problem No Apparent Adverse Event (3189)

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/21/2020

Event Type  Death  

Manufacturer Narrative

The user facility requested an evaluation of the equipment; no malfunction of the equipment was claimed.The results of the evaluation determined the gas module required n2o calibration only.

Event Description

It was reported that a patient monitored on a passport 2 monitor and gas module was having surgery and one minute into the procedure the patient's heart stopped; the patient later expired.

• Brand Name: GAS MODULE 3
• Type of Device: GAS MODULE
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13 baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzen 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13 baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzen 51810 8; CH 518108
• Manufacturer Contact: serena chen ; 1203 nanhuan avenue; guangming district; shenzhen, shenzhen 51810-6 ; CH 518106
• MDR Report Key: 9886524
• MDR Text Key: 185142093
• Report Number: 3009156722-2020-00006
• Device Sequence Number: 1
• Product Code: BZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-1900-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• 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): Death
• Patient Age: 7 YR