MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795119
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the swivel mechanism of the affiniti 70 ultrasound system¿s control panel did not lock properly 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.The philips service engineer inspected the system and determined the control panel articulation arm assembly along with the detent cable release and strut release cable required replacement to repair the system.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The customer¿s immediate concerns were addressed by replacing the system control panel arm assembly.The investigation found the failure was caused by a hardware issue in the articulation arm preventing the locking mechanism from fully engaging.The system has returned to service with no similar issues reported.

• Brand Name: AFFINITI 70
• 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: 20190973
• Report Number: 3019216-2024-00134
• Device Sequence Number: 8250133
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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 Catalogue Number: 795119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2018
• 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