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

Model Number	989605384711
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	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
Event or Problem Description
The customer reported their cx50 ultrasound system displayed an error while taking measurements during a valve replacement procedure.The procedure was completed by using another ultrasound system.No patient or user was harmed as a result of the issue.The field service engineer reloaded the software to resolve the failure.
Additional Manufacturer Narrative
A thorough investigation was performed; however, the system logs were not available due to corrupted software.The engineering team determined the issue was resolved with a software reinstallation.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.

• Brand Name: CX50
• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15587172
• Report Number: 3019216-2022-00087
• Device Sequence Number: 2810220
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: 989605384711
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/09/2023; 09/19/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 08/30/2023; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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