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

Catalog Number	795208
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As part of capa 5677695, it was identified that retrospective review activities were warranted for intracavity transducer damage if physically split, fractured, or contains sharp edges on the transducer, regardless of whether the device is in clinical use.Philips ultrasound is reporting this complaint as part of the retrospective review completed for intracavity transducer damage.It was reported the x7-2t transducer had a tear and oil seeping.This transducer was associated with an affiniti 50 ultrasound system.There was no patient or user harm associated with this event.No further information was available.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A review of the repair and inspection data for the returned probe was performed to determine cause of the reported problem.The investigation determined this is a v6-2 probe, not a x7-2t probe.The evaluation concluded damages localized to the dome head of the v6-2 probe as a result of accidental user damage.There was no indication of either non-conforming material and no indication of design anomaly requiring further action.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 21860887
• Report Number: 3019216-2025-000181
• Device Sequence Number: 4721600
• Product Code: IYN
• UDI-Device Identifier: 00884838106604
• UDI-Public: (01)00884838106604
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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 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: 03/21/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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