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

Catalog Number	795005
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported their lumify ultrasound system displayed an error during an unspecified emergency procedure.The system displayed license expired and was not able to be used.Another ultrasound system was used for the procedure.There was no user or patient harm as a result of the issue.The service engineer confirmed the reported problem and resolved the issue by re-registering the probe in a stable network.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed to determine the cause of the reported problem.The issue was unable to be reproduced.The customer's concerns were immediately addressed by re-registering the transducer.The device was returned to service with no further similar issues reported.

• Brand Name: LUMIFY
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 22902291
• Report Number: 3019216-2025-000294
• Device Sequence Number: 20833336
• Product Code: IYN
• UDI-Device Identifier: 00884838100121
• UDI-Public: (01)00884838100121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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 Catalogue Number: 795005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown