MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the swivel mechanism of their affiniti 50 ultrasound system¿s control panel did not lock properly while transporting the unit within the user facility.The failure occurred outside of clinical use, and no patient or user was harmed as a result of the issue.An investigation is underway to determine the root cause of the issue.The results of the investigation will be included in a follow-up report upon its completion.
Additional Manufacturer Narrative
A qualified field service engineer evaluated the system based on the customer complaint.The field service engineer confirmed the control panel arm is unable to lock into place.The customer's complaint was addressed by replacing the control panel arm assembly.The system functional tests passed after replacing the control panel arm, and no additional repair or analysis action was required.The suspected part was not returned for a part analysis.The system has returned to service with no similar issues reported.

• Brand Name: AFFINITI 50
• 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: 21037158
• Report Number: 3019216-2024-000182
• Device Sequence Number: 18056479
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132304
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795208
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2017
• 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