MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD ZS3 ULTRASOUND SYSTEM

Model Number	ZS3-SP
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing, pending additional information from the customer.
Event or Problem Description
It was reported that on (b)(6) 2024 the zs3 ultrasound power cord caught fire.No patient injury was reported.
Additional Manufacturer Narrative
Mindray confirmed that the customer used a third-party supply and discarded it.Mindray did not validate the power supply to be used with the zs3 ultrasound system.Since the component is unavailable for analysis, no further investigation can be performed.Mindray provided a validated power supply to be installed on the zs3 ultrasound system cart; no further issues were reported.
Event or Problem Description
It was reported that on (b)(6) 2024 the zs3 ultrasound power cord caught fire.No patient injury was reported.

• Brand Name: ZS3 ULTRASOUND SYSTEM
• Common Device Name: ZS3
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• MDR Report Key: 19895306
• Report Number: 2221819-2024-00010
• Device Sequence Number: 6482926
• Product Code: IYN
• UDI-Device Identifier: 06944904092683
• UDI-Public: 06944904092683
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024
• Report Date (Section F): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZS3-SP
• Device Catalogue Number: Z076-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 11/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown