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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD GAS MODULE 3
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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD GAS MODULE 3 Back to Search Results
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.
 
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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
MDR Report Key9901044
MDR Text Key185628694
Report Number2221819-2020-00006
Device Sequence Number1
Product Code BZK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2020,02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0998-00-1900-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date02/28/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age7 YR
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