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

Model Number	DIAGNOSTIC ULTRASOUND SYSTEM (795218)
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 30 ultrasound system¿s control panel would not lock into position.It is unknown if the incident occurred while transporting the unit within the user facility.The control panel cables were adjusted to repair the system.No patient or user was harmed as a result of the issue.
Event or Problem Description
A customer reported the swivel mechanism of their affiniti 30 ultrasound system¿s control panel would not lock into position.It is unknown if the incident occurred while transporting the unit within the user facility.The control panel cables were adjusted to repair the system.No patient or user was harmed as a result of the issue.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information and part returns, the engineering team was unable to determine the root cause of this failure.The control panel arm cable was adjusted and the arm¿s locking pin was lubricated to resolve the issue.Actions are underway to ensure the necessary information and parts are received to further investigate if this issue does recur.

• Brand Name: AFFINITI 30
• 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: 11665892
• Report Number: 3019216-2021-10045
• Device Sequence Number: 3072880
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: 00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 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: DIAGNOSTIC ULTRASOUND SYSTEM (795218)
• Device Catalogue Number: 795218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2017
• 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