MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H749ILAB220CART0
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During preparation, the screen turned blue when the device was powered on.The procedure was cancelled due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During preparation, the screen turned blue when the device was powered on.The procedure was cancelled due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; however, the field service engineer (fse) performed an on-site inspection that revealed occasional blue screens upon startup.After reseating the memory modules and graphics card, the device powered on normally, image processing was normal, and functional tests passed.Risk review: a risk review was completed and confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown (prolonged procedure moderate) was defined in the risk documentation.These event type have been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation is assigned an investigation conclusion code of unintended use error caused or contributed to event.This conclusion was selected because the reason for found blue screen after it was turned on was likely related to an unintentional interaction of the product from the available information.Furthermore, the event was resolved by properly reseating the memory modules and graphics card.Therefore, it can be concluded that "unintentional interaction" was the most probable cause of the complaint/event.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23279279
• Report Number: 2124215-2025-70317
• Device Sequence Number: 20210414
• Product Code: DQK
• UDI-Device Identifier: 08714729780205
• UDI-Public: (01)08714729780205(11)120301(10)7674
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: H749ILAB220CART0
• Device Catalogue Number: H749ILAB220CART0
• Device Lot Number: 0000007674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 03/01/2012
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown