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

Model Number	989605416151
Medical Device Problem Codes	Unintended System Motion (1430); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A customer reported the swivel mechanism of their affiniti 70 ultrasound system¿s control panel would not remain in a locked position.It is unknown if the system was being transported within the user facility when this issue was discovered.The control panel articulation arm assembly was replaced to repair the system.No patient or user was reported to be harmed as a result of the issue.
Additional Manufacturer Narrative
The customer replied this issue was discovered while the system was stationary and did not involve a horizonal control panel lock failure.The system¿s control panel would not move vertically, there was no free movement.Therefore, this issue did not pose any additional risk to the user or patient.The control panel articulation arm assembly was replaced 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.
Event or Problem Description
A customer reported the swivel mechanism of their affiniti 70 ultrasound system¿s control panel would not remain in a locked position.It is unknown if the system was being transported within the user facility when this issue was discovered.The control panel articulation arm assembly was replaced to repair the system.No patient or user was reported to be harmed as a result of the issue.

• Brand Name: AFFINITI 70
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 13874890
• Report Number: 3019216-2022-00032
• Device Sequence Number: 4716012
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 00884838056251
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2018
• 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