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.
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.

• Brand Name: ZS3 ULTRASOUND SYSTEM
• Common Device Name: ZS3 ULTRASOUND SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: jessica edwards ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958058
• MDR Report Key: 19895296
• Report Number: 3009156722-2024-00010
• Device Sequence Number: 15092412
• Product Code: IYN
• UDI-Device Identifier: 06944904092683
• UDI-Public: 06944904092683
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown