• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. A3 ANESTHESIA SYSTEM A3 ANESTHESIA DELIVERY SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. A3 ANESTHESIA SYSTEM A3 ANESTHESIA DELIVERY SYSTEM Back to Search Results
Model Number 0633F-01000-03
Device Problem No Apparent Adverse Event (3189)
Patient Problem Arrhythmia (1721)
Event Date 03/24/2022
Event Type  Death  
Manufacturer Narrative
No malfunction was alleged, the customer did not attribute the patient event to the devices but requested review of the system logs. Upon review, the systems were confirmed to have operated to specification.
 
Event Description
A patient expired prior to the initiation of a medical procedure. At the time, the patient was being monitored on the passport 12 monitor in use with the a3 anesthesia delivery system. The customer notified mindray and requested a review of system logs, no malfunction was alleged. The patient event was not attributed to the devices.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameA3 ANESTHESIA SYSTEM
Type of DeviceA3 ANESTHESIA DELIVERY SYSTEM
Manufacturer (Section D)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
1203 nanhuan avenue
guangming district
guangdong, shenzhen 51810 6
CH 518106
Manufacturer (Section G)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
1203 nanhuan avenue
guangming district
guangdong, shenzhen 51810 6
CH 518106
Manufacturer Contact
patrice martinez
800 macarthur blvd
mahwah, NJ 07430
2019958026
MDR Report Key14188568
MDR Text Key289894365
Report Number3009156722-2022-00009
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0633F-01000-03
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/20/2022
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 Unkown

Patient Treatment Data
Date Received: 04/22/2022 Patient Sequence Number: 1
-
-