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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an epiq cvx ultrasound system's control panel will not lock into place.This issue was discovered while transporting the unit within the user facility.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.A philips field service engineer reseated the grommet (bushing) and secured it into place, resolving the reported issue.A thorough engineering investigation has been performed to identify the root cause of the reported issue.The engineering team determined the failure was a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.

• Brand Name: EPIQ CVX
• 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: 19624338
• Report Number: 3019216-2024-00088
• Device Sequence Number: 6335265
• Product Code: IYN
• UDI-Device Identifier: 00884838097933
• UDI-Public: 00884838097933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/27/2024

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 Model Number: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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