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

Model Number	AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during surgery, the affiniti ultrasound system suddenly turned off automatically.There was no patient or user harm associated with this event.Multiple attempts for information regarding the case details or to obtain system logs for investigation were unsuccessful.The manufacturer is submitting a complete report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to the report will be filed.
Additional Manufacturer Narrative
An engineering investigation was initiated, however there was insufficient information to conduct the investigation.Essential information such as logs, images and timestamps were not available.The customer used a third party to address their immediate concerns and would not provide further information for the investigation.There have been no similar issues reported at the site.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 17761032
• Report Number: 3019216-2023-00137
• Device Sequence Number: 20626120
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Model Number: AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795208
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 08/28/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 08/27/2024; 09/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown