MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 5; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A customer reported encountering an incident where a patient¿s data was mixed with another exam while using their epiq ultrasound system.According to the customer, images from a previous study merged with the next patient¿s information.The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.
Additional Manufacturer Narrative
The service engineer upgraded the software to the latest version on the customer's system.The system logs were received, and an investigation was performed.However, they did not show the reported issue, and no images were provided showing the issue either.Due to insufficient data on the reported issue, no determination could be made.If pertinent information becomes available to the manufacturer on a later day, 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 5
• 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15625693
• Report Number: 3019216-2022-00092
• Device Sequence Number: 6184679
• Product Code: IYN
• UDI-Device Identifier: 00884838097919
• UDI-Public: 00884838097919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• 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 5 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/18/2023; 07/04/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 08/10/2023; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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