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

Model Number	989605416151
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the tower where the keyboard sits will not lock on their affiniti 70 ultrasound system.No patient or user was harmed as a result of the issue.
Additional Manufacturer Narrative
A philips service engineer replaced the control panel articulation arm to resolve the issue.The system has been placed back into service with no additional complaints regarding this issue reported by the customer post repair.

• Brand Name: AFFINITI 70
• 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: 16701751
• Report Number: 3019216-2023-00040
• Device Sequence Number: 17560414
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 989605416151
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 04/07/2023
• 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