MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795087
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	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An nmpa report (b)(4) was received that reported the cx50 ultrasound system could not be turned on when needed for a portable bedside exam for a critically ill patient.Another system was used for the unspecified examination.There was no patient or user harm.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed and the reported issue was not able to be reproduced.There have been no reports of similar incidents involving this ultrasound system.

• Brand Name: CX50
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23907052
• Report Number: 3019216-2025-000504
• Device Sequence Number: 9932372
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: (01)00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123754
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 795087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 04/20/2020
• 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