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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a significant ceus (contrast-enhanced ultrasound) problem in nearfield anechoic lesions when scanning with the epiq elite ultrasound system contrast ist enhanced such that anechoic lesions in the b mode are filled with contrast even though only a small amount of contrast 1.0-1.2ml bolus ist used.The exam being performed was an abdomen, ceus examination, supine.The medical indication for this ultrasound was unclear abdomen with cyst.The cyst would have been overlooked if not known before exam.There was no medical intervention, no change in the patient¿s state of health.The alleged injury was a diagnosis that are not presented as characteristic.The user alleged the patient¿s safety is at risk when incorrect diagnosis is made due to poor ceus quality.The image issue was described as: the ceus contrast is so strong in the nearfield that anechoic lesions suddenly appear filled with contrast medium or are massively superimposed with artifacts.The exam was not completed.
Additional Manufacturer Narrative
The manufacturer previously reported the epiq elite ultrasound system image related missed cyst diagnosis.No patient or user was harmed as a result of the issue.Multiple attempts to have additional information, images, and logs were unsuccessful.The manufacturer believes they will be unable to gather any further information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Additional Manufacturer Narrative
Addendum of report.A thorough investigation was conducted with the system backup and logs.The findings indicate the system was working as intended and no malfunction was determined.This imaging issue occurs when soundwaves contact bubbles.
Event or Problem Description
It was reported there was a significant ceus (contrast-enhanced ultrasound) problem in nearfield anechoic lesions when scanning with the epiq elite ultrasound system contrast ist enhanced such that anechoic lesions in the b mode are filled with contrast even though only a small amount of contrast 1.0-1.2ml bolus ist used.The exam being performed was an abdomen, ceus examination, supine.The medical indication for this ultrasound was unclear abdomen with cyst.The cyst would have been overlooked if not known before exam.There was no medical intervention, no change in the patient¿s state of health.The alleged injury was a diagnosis that are not presented as characteristic.The user alleged the patient¿s safety is at risk when incorrect diagnosis is made due to poor ceus quality.The image issue was described as: the ceus contrast is so strong in the nearfield that anechoic lesions suddenly appear filled with contrast medium or are massively superimposed with artifacts.The exam was not completed.

• Brand Name: EPIQ ELITE
• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16731596
• Report Number: 3019216-2023-00044
• Device Sequence Number: 12478182
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: 00884838099111
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 02/26/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/26/2023; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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