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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. A5 ANESTHESIA SYSTEM
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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. A5 ANESTHESIA SYSTEM Back to Search Results
Model Number A5 ANESTHESIA MACINE
Device Problem Gas/Air Leak (2946)
Patient Problem Loss of consciousness (2418)
Event Date 07/26/2022
Event Type  Injury  
Manufacturer Narrative
An investigation is in process.
 
Event Description
It was reported that during a case where a patient was being monitored on an a5 anesthesia system, three (3) hospital personnel got sick in the room due to a vaporizer leak.2 of the 3 personnel did not need medical intervention but the 3rd passed out, fell on the floor and needed medical assistance.The case was completed without consequences for the patient or the doctor performing the procedure.
 
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Brand Name
A5 ANESTHESIA SYSTEM
Type of Device
A5 ANESTHESIA
Manufacturer (Section D)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
1203 nanhuan ave
guangming district
shenzhen, guangming 51810 6
CH  518106
MDR Report Key15289707
MDR Text Key298559376
Report Number2221819-2022-00018
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/24/2022,07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberA5 ANESTHESIA MACINE
Device Catalogue Number0631F-01000-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2022
Event Location Hospital
Date Report to Manufacturer08/24/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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