MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795210
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported when using the affiniti 70 ultrasound system the acquired images were being saved in the previous patient¿s exam.The user then restarted the exam with no further complaint.The philips¿ service engineer reinstalled the software which was found to be damaged.No patient or user was harmed as a result of the issue.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
An investigation was performed including a review of the system logs and found no abnormalities.A system malfunction could not be identified related to this event.

• Brand Name: AFFINITI 70
• 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: 18192539
• Report Number: 3019216-2023-00169
• Device Sequence Number: 7264474
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 00884838056251
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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

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: 795210
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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