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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY BIOMEDICAL ELECTRONICS CO LTD GAS MODULE 2
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MINDRAY BIOMEDICAL ELECTRONICS CO LTD GAS MODULE 2 Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2014
Event Type  malfunction  
Event Description
Customer reported an issue with the gas module 2, which may have affected gas monitoring.No pt injury was reported.
 
Manufacturer Narrative
Co rep evaluated the unit.Corrections included performing preventive maintenance, replacing filter and power supply adjustment.Unit was calibrated and safety tested to factory's specifications.
 
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Brand Name
GAS MODULE 2
Type of Device
GAS MODULE
Manufacturer (Section D)
MINDRAY BIOMEDICAL ELECTRONICS CO LTD
nashan, shenzhen
CH 
Manufacturer (Section G)
MINDRAY BIOMEDICAL ELECTRONICS CO LTD
keji 12th rd south
nanshan, shenzhen 5180 57
CH   518057
Manufacturer Contact
wisara sethachutkul
800 macarthur blvd.
mahwah, NJ 07430
2019958045
MDR Report Key4567729
MDR Text Key19613750
Report Number2221819-2015-00080
Device Sequence Number1
Product Code BZK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062754
Number of Events Reported1
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 12/08/2014,12/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2015
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 Date12/08/2014
Date Manufacturer Received12/18/2014
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 Number1
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