MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) VIVID; SEE H11

Model Number	IQ V203
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Legal manufacturer: hcs wuxi - no.19 changjiang road national hi-tech dev.Zone china wuxi jiangsu, 214028.D2 common device name: system, imaging, pulsed doppler, ultrasonic.H3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.
Event or Problem Description
It was reported that after completing an ultrasound-guided procedure, the ultrasound device was moved aside.The device remained connected to the main power supply outlet and was not in use at the time of the event.Customer reported after about 54 minutes, flames were noticed to be originating from the power supply located on the system.Once the power cord was unplugged from the main supply outlet, the flame extinguished itself within 20 seconds.No injuries were reported.
Additional Manufacturer Narrative
H3: ge healthcare has concluded its investigation.Due to the customer discarding the power cord, a comprehensive analysis of the power cord could not be performed.Based on internal expert analysis review of photos provided by the customer and all the evidence supplied, the investigation showed that the customer was not using a gehc approved cord that was designed to be used with the vivid iq system.The manual for the vivid iq system indicates that the customer is required to use only the power cord provided by gehc.Using an unapproved power cord can potentially cause thermal issues.The system has been corrected by installing a gehc approved power cord and cart power box.After testing, the system has been returned to full functions.No further actions are planned by gehc.

• Brand Name: VIVID
• Common Device Name: SEE H11
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: karen hoffman ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226
• MDR Report Key: 21439404
• Report Number: 9710602-2025-00279
• Device Sequence Number: 14540268
• Product Code: IYN
• UDI-Device Identifier: 00840682139694
• UDI-Public: (01)00840682139694(11)210622
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: IQ V203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown