MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7W; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their 3d9-3v transducer broke in half during the cleaning process.There was no harm or injury reported to the patient or user, the device the was not in clinical use.Analysis was performed by onsite field service engineer who confirmed the reported issue.The results of the analysis confirmed the transducer was broken in half near the base.The issue was resolved by replacing the transducer and the product is back in service.Philips has started an investigation into this complaint.
Additional Manufacturer Narrative
A thorough investigation was performed on the damaged probe for the dimensional integrity, bond strength, and presence of adequate bonding adhesive.Based on the analysis, it can be concluded that an unintended excessive force between the two sections (front and rear) of the probe caused the probe to become separated at the joint.
Additional Manufacturer Narrative
H11: inadvertently omitted statement: as part of capa 5677695, it was identified that retrospective review activities were warranted for intracavity transducer damage if physically split, fractured, or contains sharp edges on the transducer, regardless of whether the device is in clinical use.Philips ultrasound is reporting this complaint as part of the retrospective review completed for intracavity transducer damage.

• Brand Name: EPIQ 7W
• 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: 21380449
• Report Number: 3019216-2025-000034
• Device Sequence Number: 12854426
• Product Code: IYN
• UDI-Device Identifier: 00884838097889
• UDI-Public: (01)00884838097889
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 05/02/2025

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: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 02/14/2025; 05/02/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/20/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2014
• 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