MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 30; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795218
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the c9-4v transducer had separation of the head from the body of the transducer.This was associated with an affiniti 30 ultrasound system.There was no patient or user harm associated with this event.There was no further information available.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed that determined the separation of the head from the body of the transducer was likely a result of accidental user damage.There was no indication of either non-conforming material and no indication of design anomaly requiring further action.

• Brand Name: AFFINITI 30
• 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: 23573137
• Report Number: 3019216-2025-000441
• Device Sequence Number: 9868692
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: (01)00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160807
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 795218
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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