MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	AFFINITI 50 ULTRASOUND SYSTEM
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the affiniti ultrasound system shutdown during a patient examination and was accompanied by a burning smell and some smoke was emitted.There was no patient or user harm associated with this event.After a few minutes, no further smoke was observed, and the device was removed from service.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information received noted that there was no actual 'smoke' emitted from the ultrasound system.The internal system air filter was not properly maintained and very dirty.Dust blew out from the air vent, and the customer mistook it for smoke.The dirty air filter also was the cause of the system shutdown and resultant overtemperature message due to impeded air flow.Although the device did not perform as intended, a dirty system air filter would not be likely to cause or contribute to a death or serious injury.As such, this event was determined to be not reportable.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 22682764
• Report Number: 3019216-2025-000265
• Device Sequence Number: 9048154
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/07/2025
• Date Device Manufactured: 10/30/2020
• 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