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

Catalog Number	795190
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an affiniti ultrasound system monitor detached from the articulating arm support.No patient or user was harmed as a result of the issue.The field service engineer replaced the articulating monitor arm to resolve the issue.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
Sending supplemental report to populate become aware date in the 'date received by manufacturer' field for the initial report received by fda on july 18, 2024.This date was inadvertently left blank.
Additional Manufacturer Narrative
Root cause was unable to be determined as the suspect part could not be obtained for further failure analysis.Engineering has opened a product defect investigation to look at failures related to the monitor knuckle.The system has returned to service with no similar 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 19771075
• Report Number: 3019216-2024-00102
• Device Sequence Number: 8605187
• Product Code: IYN
• UDI-Device Identifier: 00884838106598
• UDI-Public: 00884838106598
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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
• Device Catalogue Number: 795190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/04/2024; 12/04/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/06/2024; 12/27/2024
• Date Device Manufactured: 07/31/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown