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

Catalog Number	795218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was damage to the membrane of an intracavity transducer, exposing the metal underneath the membrane, resulting in a failed leakage current test.The c9-4v transducer was associated with the affiniti 30 ultrasound system at the customer's site.The issue was discovered while the device was outside of clinical use and there was no patient or user harm associated with this event.The philips service engineer evaluated the transducer and confirmed the membrane was damaged.The transducer was replaced to address the customer's immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was unable to be performed to determine the cause of the reported problem.The transducer was no longer available; therefore, no repair or evaluation data could be obtained.No additional investigation is possible.

• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 21721584
• Report Number: 3019216-2025-000067
• Device Sequence Number: 13120994
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: (01)00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Catalogue Number: 795218
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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