MAUDE Adverse Event Report: MINDRAY BIO-MEDICAL ELECTRONICS CO LTD GAS MODULE III

Model Number 0998-00-0481-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Customer reported an issue with the gas module iii, which may have affected co2 monitoring.No pt injury was reported.

Manufacturer Narrative

Unit was evaluated, unable to confirm the reported problem.

• Brand Name: GAS MODULE III
• Type of Device: GAS MODULE
• Manufacturer (Section D): MINDRAY BIO-MEDICAL ELECTRONICS CO LTD; nanshan, shenzhen ; CH
• Manufacturer (Section G): MINDRAY BIO-MEDICAL ELECTRONICS CO LTD; keji 12th rd s; nanshan, shenzhen 5180 57; CH 518057
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958045
• MDR Report Key: 4567411
• MDR Text Key: 5556411
• Report Number: 2221819-2015-00058
• Device Sequence Number: 1
• Product Code: BZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0481-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1