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

Model Number	EPIQ CVXI DIAGNOSTIC ULTRASOUND SYSTEM (795232)
Medical Device Problem Codes	No Device Output (1435); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the power regulator board and system logs will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
A customer reported their epiq cvxi ultrasound system shut down unexpectedly during an open heart procedure.The procedure in progress was completed successfully using the same ultrasound system after a system restart.A philips service engineer replaced the power regulator board and ordered updated software to resolve the immediate issue.There was no allegation of altered patient outcome as a result of the issue.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue, including a technical and clinical evaluation of this event.The engineering team determined a system temperature alert displayed options for a 30 minute delay in shutting down the system.However, the system was actually not overheating, and a power regulator board was causing a false alarm.Once the system is powered down the system can be restarted immediately to regain functionality.Therefore, either the 30 minute warning time is adequate, or it is unnecessary and, given the ability of the physician to select when the reboot occurs, the reboot time does not create incremental risk of harm to the patient.The immediate issue was resolved by restarting the system at the time of occurrence.A solution has been included in an updated software revision.
Event or Problem Description
A customer reported their epiq cvxi ultrasound system shut down unexpectedly during an open heart procedure.The procedure in progress was completed successfully using the same ultrasound system after a system restart.A philips service engineer replaced the power regulator board and ordered updated software to resolve the immediate issue.There was no allegation of altered patient outcome as a result of the issue.

• Brand Name: EPIQ CVXI
• 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: 12983940
• Report Number: 3019216-2021-10156
• Device Sequence Number: 17569669
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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 CVXI DIAGNOSTIC ULTRASOUND SYSTEM (795232)
• Device Catalogue Number: 795232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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