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

Model Number	AFFINITI 50 ULTRASOUND SYSTEM
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	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer will be dispatched to the site to evaluate the monitor and determine the root cause of the issue which will be included in a follow up report upon evaluation completion.
Event or Problem Description
The customer reported that the affiniti ultrasound system¿s monitor arm was defective.It is unknown at this time if the monitor arm detached or if it had a locking issue during transport within the site.No patient or user was harmed as a result of the issue.The field service engineer will be dispatched to the site to evaluate the monitor and determine the root cause of the issue which will be included in a follow up report upon evaluation completion.
Additional Manufacturer Narrative
The field service engineer confirmed that the issue pertained to the horizontal swivel motion of the monitor arm.He confirmed the ultrasound system was stationery at the time this event occurred.The system has been returned to service with no additional issues reported.

• Brand Name: AFFINITI 50
• 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: 16544587
• Report Number: 3019216-2023-00027
• Device Sequence Number: 12260391
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: AFFINITI 50 ULTRASOUND SYSTEM
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• 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