MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intracavity model 3d9-3v transducer was leaking fluid from the tip of the probe dome.The probe was associated with the affiniti 70 ultrasound system at the customer¿s site.No patient or user was harmed as a result of the issue.In response to the issue, the customer received a replacement transducer.The biomed confirmed that the new replacement transaction is working to factory specifications and the ultrasound system is back in clinical use.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
Philips initiated an investigation to identify the cause of the reported issue.However, the investigation could not be performed as the transducer could not be obtained from the customer.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.The system has been returned to service, and no similar issues have been reported.

• Brand Name: AFFINITI 70
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 23853261
• Report Number: 3019216-2025-000496
• Device Sequence Number: 9445306
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795210
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2019
• 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