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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received report (b)(4) from the fda's medsun program, which reported damage to a tee transducer that was identified following a transesophageal echocardiogram.After removing the x8-2t transducer from the patient, an inch and a half area of missing sheath was found.The patient had a ct scan, and the results did not show any discernable radiopaque foreign object or evidence of bowel obstruction.There was no patient or user harm associated with this event.An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow-up report upon its completion.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the medwatch report number.The information is in the g10 data field.
Additional Manufacturer Narrative
The customer declined service and support to replace the suspect transducer.As a result, the transducer remains at the customer site and could not be returned for failure analysis.
Additional Manufacturer Narrative
The customer declined service and support to replace the suspect transducer.As a result, the transducer remains at the customer site and could not be returned for failure analysis.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 CVX
• 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: 20071684
• Report Number: 3019216-2024-00120
• Device Sequence Number: 3048501
• Product Code: IYN
• UDI-Device Identifier: 00884838097933
• UDI-Public: (01)00884838097933(21)US721B1197
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup,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 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795231
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided; 02/14/2025; 05/02/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/16/2024; 03/12/2025; 05/02/2025
• Date Device Manufactured: 07/22/2021
• 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