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

Model Number	795210
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intracavity c10-3v transducer seal was cracked between the two halves of the transducer, resulting in cleaning fluid entering and causing a green substance at the bottom of the transducer connector.The transducer was associated with the affiniti 70 ultrasound system at the customer¿s site.The issue was discovered outside of clinical use, during cleaning and inspection, and the transducer was removed from service.No patient or user was harmed as a result of the issue.The philips service engineer replaced the transducer to address the customer¿s immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.

• Brand Name: AFFINITI 70 ULTRASOUND SYSTEM
• 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: 22391635
• Report Number: 3019216-2025-000241
• Device Sequence Number: 21099703
• Product Code: IYN
• UDI-Device Identifier: 00884838106611
• UDI-Public: (01)00884838106611
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: 795210
• 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: 06/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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