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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD M9 DIAGNOSTIC ULTRASOUND SYSTEM,
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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD M9 DIAGNOSTIC ULTRASOUND SYSTEM, Back to Search Results
Model Number M9 DIAGNOSTIC ULTRASOUND SYSTEM,
Device Problems No Audible Alarm (1019); Fire (1245); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
The facilities (third-party) biomedical service replaced the adapter and the system was returned to use.Investigation is pending return of the subject components.
 
Event Description
The customer reported that on (b)(6) 2021 at approximately 2:00pm a burning smell and smoke was emitted from the ac adapter in use with an m9 ultrasound system.Subsequently, a small flame from the power brick was observed.The adaptor was immediately unplugged from the wall outlet and a melted spot was noted between the cord and power brick.No patient injury was reported.
 
Event Description
The customer reported that on (b)(6) 2021 at approximately 2:00pm a burning smell and smoke was emitted from the ac adapter in use with an m9 ultrasound system.Subsequently, a small flame from the power brick was observed.The adaptor was immediately unplugged from the wall outlet and a melted spot was noted between the cord and power brick.No patient injury was reported.
 
Manufacturer Narrative
The adapter and line cord involved with the occurrence is not available for investigation; therefore, no final root cause can be stablished.
 
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Brand Name
M9 DIAGNOSTIC ULTRASOUND SYSTEM,
Type of Device
M9 DIAGNOSTIC ULTRASOUND SYSTEM,
Manufacturer (Section D)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
1203 nanhuan avenue
guangming district
shenzhen, guangming 51810 6
CH  518106
MDR Report Key11825975
MDR Text Key250650334
Report Number2221819-2021-00007
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM9 DIAGNOSTIC ULTRASOUND SYSTEM,
Device Catalogue Number2116E-PA00001
Was Device Available for Evaluation? No
Distributor Facility Aware Date08/25/2021
Event Location Hospital
Date Report to Manufacturer08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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