MAUDE Adverse Event Report: PHILIPS ULTRASOUND INNOSIGHT; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795001
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that a thrombus was not visualized on the innosight ultrasound system during a portable focused echo scan and pathology.A repeat echo was performed at a later date using a different system.The thrombus was visualized.The patient received a bone marrow transplant and subsequently died.An internal site investigation is currently underway to determine whether the lack of visualization of the substrate contributed to cause of death.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed by the innosight ultrasound system manufacturer to determine the cause of the reported issue.It was determined that the image quality was as expected.Therefore, based on the information received, it does not appear a device malfunction caused or contributed to the reported event; however, this may indicate a use issue for not adjusting imaging settings e.G.Parameters, modes, to enhance the image further.No further action is necessary at this time.No similar issues for this device have been reported.

• Brand Name: INNOSIGHT
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 22052180
• Report Number: 3019216-2025-000199
• Device Sequence Number: 8908333
• Product Code: IYN
• UDI-Device Identifier: 04719873000012
• UDI-Public: (01)04719873000012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 795001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 09/19/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown