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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the epiq cvxi ultrasound system displayed an error during use and then when the user attempted to switch probes, the system shut off.Multiple attempts were made for additional information; however, they were unsuccessful.Out of an abundance of caution, this event will be reported.There was no harm associated with this event.The service engineer evaluated the equipment and replaced the x8-2t transducer to resolve the issue.The probe caused an error when connected to the system.Philips has started an investigation for this complaint.
Event or Problem Description
It was reported the epiq cvxi ultrasound system displayed an error during use and then when the user attempted to switch probes, the system shut off.Multiple attempts were made for additional information; however, they were unsuccessful.Out of an abundance of caution, this event will be reported.There was no harm associated with this event.The service engineer evaluated the equipment and replaced the x8-2t transducer to resolve the issue.The probe caused an error when connected to the system.Philips has started an investigation for this complaint.3019216-2023-00174 mfr report number for initial.
Additional Manufacturer Narrative
It was previously reported out of an abundance of caution, the epiq ultrasound system displayed an error during use and then when the user attempted to switch probes, the system shut off during an unknown procedure.However, additional information was received that reported the exam was diagnostic and the patient¿s condition was not critical.The system was being used in the ultrasound exam room.Therefore, this event is not likely to cause or contribute to a serious injury if it were to reoccur.

• 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: 18292308
• Report Number: 3019216-2023-00174
• Device Sequence Number: 17689627
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown