MAUDE Adverse Event Report: MINDRAY BIO-MED ELECTRONICS CO. LTD. GAS MODULE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2015

Event Type  malfunction  

Event Description

Customer reported an issue with the gas module which may have affected patient monitoring.No patient injury was reported.

Manufacturer Narrative

The device was evaluated.Corrections included calibrating the gas module.Performance tested to factory specifications.

• Brand Name: GAS MODULE
• Type of Device: GAS MODULE
• Manufacturer (Section D): MINDRAY BIO-MED ELECTRONICS CO. LTD.; nashan; shenzhen ; CH
• Manufacturer (Section G): MINDRAY BIO-MED ELECTRONICS CO. LTD.; keji 12th road south; nanshan; shenzhen 5180 57; CH 518057
• Manufacturer Contact: patrice soriano ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958026
• MDR Report Key: 4810958
• MDR Text Key: 5925835
• Report Number: 2221819-2015-00233
• 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: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2015
• Date Manufacturer Received: 04/14/2015
• 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