MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795210
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the c10-3v transducer had damage to the lens with exposed circuitry.This was associated with an affiniti 70 ultrasound system.There was no patient or user harm.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The investigation confirmed the hole in the lens.The cause was a result of improper maintenance.There was no indication of either non-conforming material and no indication of design anomaly requiring further action.The transducer was replaced to address the customer's immediate concerns, and the replacement transducer is in service with no further similar issues.

• Brand Name: AFFINITI 70
• 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: 23730388
• Report Number: 3019216-2025-000471
• Device Sequence Number: 9722924
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 795210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2018
• 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