MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ ELITE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	795234
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported they were not seeing the needle tip during liver/renal interventional procedures with the c5-1 transducer and on the epiq elite ultrasound.The procedure was not continued and was rescheduled.A philips field service engineer replaced the system hard drives and updated the system software to resolve this issue.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
A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the system was performing as designed.The system is safe and effective for its intended use.The immediate issue was resolved by replacing hard drives and upgrading the software.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.
Additional Manufacturer Narrative
Previously reported: a thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the system was performing as designed.The system is safe and effective for its intended use.The immediate issue was resolved by replacing hard drives and upgrading the software.Correction: a thorough investigation was performed by engineering to identify the root cause of the reported issue.The engineering team determined the system was performing as designed.Suggestions were provided on how to improve the image quality and forwarded to the customer.The system is safe and effective for its intended use.No further issues have been reported.

• Brand Name: EPIQ ELITE
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 18025397
• Report Number: 3019216-2023-00155
• Device Sequence Number: 7615823
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: 00884838099111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200304
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2025

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: 795234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 10/06/2023; 02/26/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 03/08/2024; 09/04/2024; 03/05/2025
• 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