MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	795005
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported the lumify ultrasound system was not available during an emergent procedure.The ultrasound system generated an error code during cpr (cardiopulmonary resuscitation).The user exchanged the system and the procedure was completed.The event resulted in a patient death.Additional information is being obtained to determine whether the device caused or contributed to the reported death.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed, including manual reproduction testing using another device to identify the cause of the reported issue.The engineering team determined that the transducer usb-c connector can exhibit reduced mechanical retention when mated to the tablet port.This can lead to an intermittent issue where the firmware version is unrecognized.When this occurs a prompt to reregister the transducer is displayed.

• Brand Name: LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23719604
• Report Number: 3019216-2025-000462
• Device Sequence Number: 8449319
• Product Code: IYN
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K162549
• 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): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 795005
• Device Catalogue Number: 795005
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown