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

Model Number	989605457591
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	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect tilt swivel arm assembly is anticipated.Evaluation of the arm will be included in a follow-up report upon its return and investigation completion.
Event or Problem Description
A customer reported the monitor fell from their affiniti 30 ultrasound system while transporting the unit within the user facility.The monitor wires prevented the monitor from completely detaching from the system.A philips service engineer installed a new tilt swivel arm 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
Although the suspect arm was inadvertently discarded, 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.The engineering team determined the failure resulted from an assembly error causing misaligned screw threads to shear away from a secured position.A design change that involves securing the monitor arm with a tab and slot instead sole reliance on screws has been implemented in (b)(6) 2019 and prevents potential recurrence of this assembly error.H3 other text : suspect part was inadvertently discarded prior to return for evaluation.
Event or Problem Description
A customer reported the monitor fell from their affiniti 30 ultrasound system while transporting the unit within the user facility.The monitor wires prevented the monitor from completely detaching from the system.A philips service engineer installed a new tilt swivel arm 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.

• 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: 13690895
• Report Number: 3019216-2022-00025
• Device Sequence Number: 14776102
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: 00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: 989605457591
• Device Catalogue Number: 795218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2020
• 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