MAUDE Adverse Event Report: GE MEDICAL SYSTEMS U/S & PRIMARY CARE DIAGNOSTICS LOGIQ E9; SEE H11

Model Number	5205000-8
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced difficulties powering on the system console located in the interventional radiology (ir) department.After attempting to use several different outlets, including checking the breaker switch, the staff reconnected the system and powered it on.At that point, a flame was observed originating from the system.The flame self-extinguished immediately after the system was unplugged.No injuries were reported.
Additional Manufacturer Narrative
Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.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.
Additional Manufacturer Narrative
Ge healthcare¿s investigation has been completed.Examination of the returned power supply showed significant thermal damage to the c20 inlet and ac breaker switch, including a fully disintegrated ¿live¿ prong, while internal components remained intact with no evidence of shorting.The investigation determined that the thermal event was caused using a non-ge healthcare, unapproved power cord whose connector design prevented proper seating and engagement with the system¿s c20 inlet.This improper fit likely resulted in inadequate electrical contact, leading to arcing, overheating, and extensive thermal damage to both the power cord and the inlet.After replacing the damaged inlet and switch, the ge healthcare power supply operated normally during extended testing, confirming it was not defective.The user and service manuals clearly specify to use approved power cords and include the proper attachment procedure.The investigation concluded that the event was due to misuse involving an unapproved part and not attributable to any ge healthcare product or process deficiencies.The risk analysis determined that no additional mitigations are available to reduce the risk, and the risk has been reduced as far as possible.The equipment has been corrected and returned to use.No further actions are planned by ge healthcare.

• Brand Name: LOGIQ E9
• Common Device Name: SEE H11
• Manufacturer (Section D): GE MEDICAL SYSTEMS U/S & PRIMARY CARE DIAGNOSTICS; 9900 innovation drive; wauwatosa, WI 53226
• Manufacturer (Section G): GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC; 9900 innovation drive; wauwatosa, WI 53226
• Manufacturer Contact: karen hoffman ; 3000 n. grandview blvd; mail drop: w440; waukesha, WI 53188
• MDR Report Key: 23855472
• Report Number: 3005860720-2025-00027
• Device Sequence Number: 10144081
• Product Code: IYN
• UDI-Device Identifier: 00840682124324
• UDI-Public: (01)00840682124324(11)170613
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 5205000-8
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2017
• 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