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

Model Number	AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM (795190)
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an incident where the swivel mechanism of their affiniti cvx ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.A philips service engineer tightened an internal screw to repair the system.No patient or user was harmed as a result of the issue.The ultrasound system has been returned to service with no additional issues reported.
Additional Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information and part returns, the engineering team was unable to determine the root cause of this failure.An internal screw was tightened to resolve the issue and no additional similar problems have been reported post repair.Actions are underway to ensure the necessary information and parts are received to further investigate if this issue does recur.
Event or Problem Description
The customer reported an incident where the swivel mechanism of their affiniti cvx ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.A philips service engineer tightened an internal screw to repair the system.No patient or user was harmed as a result of the issue.The ultrasound system has been returned to service with no additional issues reported.

• Brand Name: AFFINITI CVX ULTRASOUND SYSTEM
• 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: 12831915
• Report Number: 3019216-2021-10148
• Device Sequence Number: 11103125
• Product Code: IYN
• UDI-Device Identifier: 00884838101043
• UDI-Public: 00884838101043
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212777
• 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: Biomedical Engineer
• 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: AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM (795190)
• Device Catalogue Number: 795190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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