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

Catalog Number	795232
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the epiq 5 ultrasound system was not available during a critical procedure.During a transcatheter edge to edge repair (teer), a mitral valve repair procedure, the patient developed a pericardial effusion in the left atrium.While observing and evaluating the pericardial effusion using the epiq system and a tee, the epiq crashed.The system was restarted, and it took about 10 minutes before imaging was available.The patient had a sternotomy for the pericardial effusion and the outcome was positive.The epiq system did not cause or contribute to the pericardial effusion.There was no patient or user harm associated with this event.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information reported, during the transcatheter edge to edge repair (teer), the user and team noticed a pericardial tamponade on the ultrasound images, then the team performed mechanical resuscitation of the patient.The epiq ultrasound system may have been moved during that time to access the patient.The system crashed and displayed a message to restart the system.The system was restarted and took about 8 minutes to reboot.The epiq ultrasound system was not related to the patient¿s tamponade.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation to determine the reported failure was performed.The issue was verified in a system log review, the analysis determined contamination of the probe connector led to a system error.A part analysis was not able to be performed as there was no part replaced.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: 19623959
• Report Number: 3019216-2024-00090
• Device Sequence Number: 6359972
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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 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: 06/13/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 09/23/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/16/2024; 09/26/2024
• 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