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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a thyroid mass appeared cystic on their epiq ultrasound machines.No patient or user was harmed as a result of the issue.An investigation is underway to determine the root cause of the issue.A follow up report will be provided upon investigation completion.
Additional Manufacturer Narrative
The manufacturer previously reported the epiq elite ultrasound system a thyroid mass appeared cystic.No patient or user was harmed as a result of the issue.Multiple attempts to have additional information, images, and type of probe used 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
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.

• Brand Name: EPIQ ELITE
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, 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: 15986352
• Report Number: 3019216-2022-00115
• Device Sequence Number: 14884079
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: 00884838099111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 11/16/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 04/28/2023; 09/06/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown