MAUDE Adverse Event Report: MINDRAY DS USA, INC. GAS MODULE III

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Customer reported an intermittent error message from the gas module iii, which may have affected gas monitoring.No patient injury was reported.

Manufacturer Narrative

Company representative evaluated the unit.Corrections included replacements of the unit's tubing, o2 filter, and co2 absorber and filter.Problem was resolved.Unit was calibrated and safety tested to factory's specifications.

• Brand Name: GAS MODULE III
• Type of Device: GAS MODULE
• Manufacturer (Section D): MINDRAY DS USA, INC.; mahwah NJ
• Manufacturer Contact: wisara sethacutkul ; 800 macarthur blvd.; mahwah, NJ 07430-0619 ; 2019958045
• MDR Report Key: 3916335
• MDR Text Key: 4666682
• Report Number: 2221819-2014-00192
• Device Sequence Number: 1
• Product Code: BZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 062754
• 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: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/21/2014
• 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