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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
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 were being added to the wrong patient study.The user identified the data mix-up, and there was no allegation of altered patient outcomes as a result of the issue.
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.
Additional Manufacturer Narrative
The manufacturer previously reported a customer encountered an incident where a patient¿s data was mixed with another exam while using their epiq ultrasound system.There was no allegation of patient harm or injury.Additional information received by the manufacturer indicates the epiq ultrasound system was not the correct device for the alleged malfunction.The field service engineer determined an echo navigator system was being used at the time of reported event, and no allegation was received against an epiq ultrasound system.The allegation was forwarded to the philips medical systems nederland b.V.For review and reportability determination.No additional review is required for the epiq ultrasound system.

• Brand Name: EPIQ CVXI
• 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: 17075518
• Report Number: 3019216-2023-00077
• Device Sequence Number: 6688852
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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,Company Representative
• 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 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795232
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2019
• 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