MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 30; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795218
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An nmpa report 1335143062024000113 was received and reported a misdiagnosis, misjudgment, and unable to receive timely treatment to a patient.The affiniti 30 ultrasound system was being used for an unspecified patient examination.The 2d gain of the system could not be adjusted, resulting in image distortion, and affecting the diagnosis of the patient.There was no reported patient or user harm as a result of this issue.No further information is available at this time; attempts to gather more details are underway.Philips has started an investigation of this complaint.If further information becomes available or upon completion of the investigation, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: it was previously reported there was a misdiagnosis, misjudgment and unable to receive timely treatment to a patient due to an image distortion.Additional information reported there was not a misdiagnosis.There was no patient harm or medical intervention required.The image distortion was always recognizable by the user.The patient exam was completed on another ultrasound system.This issue is not likely to cause or contribute to a death or serious injury.

• Brand Name: AFFINITI 30
• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 19557955
• Report Number: 3019216-2024-00085
• Device Sequence Number: 4851608
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: 00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160807
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 795218
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/16/2024
• 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