MAUDE Adverse Event Report: PHILIPS ULTRASOUND AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795208
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	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A thorough investigation has been performed to identify the root cause of the reported issue, including a manufacturing evaluation and analysis of the involved monitor arm variant.Design improvement changes are under consideration to prevent potential recurrence.The system remains at the customer site with no further repair actions anticipated.
Event or Problem Description
A customer reported the display monitor mounting bracket broke on their affiniti 50 ultrasound system.The site¿s biomedical department ordered a replacement tilt swivel arm bracket kit to repair the system.No patient or user was harmed as a result of the issue.The system has been returned to service with no additional issues reported.
Event or Problem Description
A customer reported the display monitor mounting bracket broke on their affiniti 50 ultrasound system.The site¿s biomedical department ordered a replacement tilt swivel arm bracket kit to repair the system.No patient or user was harmed as a result of the issue.The system has been returned to service with no additional issues reported.
Additional Manufacturer Narrative
It was identified that the previously submitted report id# 3019216-2024-00152 submitted on 2024-10-24 needed some clarification.Excessive force outside of the normal operating range was identified as the cause of the incident.There is no fault in the device's current design as the device¿s arm has the capacity to hold five times the weight of the mounted display.

• Brand Name: AFFINITI 50
• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20527850
• Report Number: 3019216-2024-00152
• Device Sequence Number: 15449623
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244(21)US617D0750
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/30/2025

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: 795208
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2017
• 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