MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC SPARQ ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	SPARQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their sparq ultrasound system shut down while performing a nerve block for a patient.After rebooting, the system displayed an error message and could not be started, which delayed the procedure.There was no patient or user harm associated with this event.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
The customer's repair of the system is maintained by a third party and information could not be obtained by philips for failure analysis.As the customer declined service and support and would not provide pertinent information required for the investigation, no further investigation could be performed.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 23292736
• Report Number: 3019216-2025-000361
• Device Sequence Number: 14675021
• Product Code: ITX
• UDI-Device Identifier: 00884838028098
• UDI-Public: (01)00884838028098
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: SPARQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795090
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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