MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 7G ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 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	10/06/2021
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.According to the customer, another patient¿s data appeared in the selected patients study after exporting to their pacs.The data mix-up was identified by the user and did not lead to any altered patient outcome.
Event or Problem Description
A customer reported encountering an incident where a patient¿s data was mixed with another exam.According to the customer, another patient¿s data appeared in the selected patients study after exporting to their pacs.The data mix-up was identified by the user and did not lead to any altered patient outcome.
Additional Manufacturer Narrative
The ultrasound system was tested at the customer site by the philips service engineer and adjusting the export image setting to end-exam resolved this issue.A thorough investigation was performed to identify the root cause of this issue, including an evaluation and analysis of the logs from the ultrasound system.The software engineering team was unable to identify the event from the system logs so no system malfunction could be confirmed.The system is still in service with no additional similar issues reported.

• Brand Name: EPIQ 7G ULTRASOUND SYSTEM
• 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: 12756188
• Report Number: 3019216-2021-10143
• Device Sequence Number: 14232909
• Product Code: IYN
• UDI-Device Identifier: 00884838097865
• UDI-Public: 00884838097865
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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