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

Model Number	989605410251
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	02/23/2022
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 arm bracket broke off of their affiniti 50 ultrasound system while transporting the unit within the user facility.A philips service engineer ordered a replacement tilt swivel arm that was installed by the customer biomedical department 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 monitor arm bracket broke off of their affiniti 50 ultrasound system while transporting the unit within the user facility.A philips service engineer ordered a replacement tilt swivel arm that was installed by the customer biomedical department 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 january 2019 and prevents potential recurrence of this assembly error.

• Brand Name: AFFINITI 50
• 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: 13827140
• Report Number: 3019216-2022-00030
• Device Sequence Number: 4467378
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: 989605410251
• Device Catalogue Number: 795208
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2019
• 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