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

Catalog Number	795087
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An nmpa report 1233502042024000124 was received and reported a cx50 ultrasound system was not available during a critical procedure.The cx50 ultrasound system was found to be unusable for an unspecified reason when attempted to be used for a bedside examination and ultrasound guided internal jugular vein catheterization.The exam was performed on a patient with unstable circulation and concomitant septic shock.A backup ultrasound system was used for the examination.There was no reported patient or user harm as a result of this issue.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The service engineer inspected the actual system and verified the system could not boot up and displayed the philips logo.The software was reinstalled to resolve the customer¿s immediate concerns.The engineer team investigated using the customer¿s version of software, a system was rebooted multiple times to determine if the system would hang.The system worked as intended and the issue was not able to be reproduced.

• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 19548278
• Report Number: 3019216-2024-00083
• Device Sequence Number: 4734523
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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 Catalogue Number: 795087
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 01/10/2022
• 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