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

Catalog Number	795208
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
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 c9 4v transducer head was separating from the body.This transducer was associated with an affiniti 50 ultrasound system.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
H11: the initial report inadvertently reported an incorrect date received by mfg (g3) and should have been 21mar2025.A thorough investigation was unable to be performed to determine the cause of the reported problem.The transducer was no longer available; therefore, no repair or evaluation data could be obtained.No additional investigation is possible.

• 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: 21805210
• Report Number: 3019216-2025-000084
• Device Sequence Number: 7409091
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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