MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 30; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795218
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the monitor arm detached from the articulation arm assembly of their affiniti 30 ultrasound system.No patient or user was harmed as a result of 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
A thorough engineering investigation has been performed to identify the root cause of the reported issue.The engineering team determined the detachment of the monitor arm was caused by the porosity of the cast aluminum knuckle, combined with sudden shocks during transit, which can lead to the development of stress cracks and potential failure.The knuckle supports the entire cantilevered display, subjecting it to significant stress.Repeated or violent shocks during transit can cause the cast aluminum knuckle to crack and ultimately break.

• Brand Name: AFFINITI 30
• 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: 17685904
• Report Number: 3019216-2023-00134
• Device Sequence Number: 17712629
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: (01)00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160807
• 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): 06/21/2024

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: 795218
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2017
• 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