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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the epiq cvxi ultrasound system was not available during a critical procedure.A patient was in the cath lab with a suspected vsd (ventricular septal defect) following an mi (myocardial infarction) and required ultrasound imaging to verify.The ultrasound system was displaying error codes and was unable to boot up.The cardiac sonographer attempted multiple times to boot the system without success.Another vascular access machine was used to scan the patient to verify the vsd.At that points the catheterization procedure was stopped.The user again attempted to boot the ultrasound system after removing the batteries which was successful.The system was used to capture images for documentation of the medical condition.The patient¿s medical condition was determined to be terminal, and the patient died on (b)(6) 2024.The ultrasound system did not cause or contribute to the death.There was no reported patient or user harm associated with this event.The philips service engineer evaluated the ultrasound system and was not able to boot up the device.When attempting to download the log files they were found to be corrupted and not able to be opened.The engineer reloaded the software to repair the system.The system was tested and rebooted multiple times without failure.The system was returned to clinical use.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
H10: a thorough investigation was performed to determine the cause of the reported problem.The engineering team was not able to reproduce the reported issue.The system has returned to service with no similar issues reported.

• 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: 20294480
• Report Number: 3019216-2024-00139
• Device Sequence Number: 7208772
• Product Code: IYN
• UDI-Device Identifier: 00884838107533
• UDI-Public: (01)00884838107533
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 08/30/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: Female