MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM CLOSE; IYN

Model Number	989605408541
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the c10-3v transducer had a hold in the lens, resulting in exposed metal.The transducer was associated with the epiq 5 ultrasound system at the customer¿s site.The issue was discovered outside of clinical use and no patient or user was harmed as a result of the issue.A philips remote service engineer initiated the replacement process to resolve the customer¿s immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.

• Brand Name: EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM CLOSE
• Common Device Name: IYN
• 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: 24203738
• Report Number: 3019216-2026-100022
• Device Sequence Number: 17513910
• Product Code: IYN
• UDI-Device Identifier: 00884838047686
• UDI-Public: (01)00884838047686
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: 989605408541
• Device Catalogue Number: 795204
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2017
• 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