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

Model Number	989605410251
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an affiniti 50 ultrasound system¿s monitor, during clinical use fell off without detaching as the articulating arm broke in half.No patient or user was harmed as a result of the issue.The field service engineer replaced the articulating monitor arm to resolve the issue.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.
Additional Manufacturer Narrative
A qualified field service engineer evaluated the system based on the customer complaint and the issue was confirmed.The field service engineer replaced the monitor articulating arm to resolve the customer¿s immediate concern.An investigation was performed that confirmed the reported problem and determined the cause was related to the knuckling component.There have been no further similar issues reported.

• Brand Name: AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM
• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23438982
• Report Number: 3019216-2025-000410
• Device Sequence Number: 14635903
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: 989605410251
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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