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

Catalog Number	795005
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Mydriasis (4856)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An engineering investigation was performed to identify the root cause of the reported issue.However, system log analysis was not possible as they were not provided.The philips field service engineer determined that the customer was not using the lumify system properly.When starting up the tablet as instructed in the ifu, the lumify transducer should not be connected to the tablet.Lumify software and test teams attempted to reproduce this issue internally but were unable to replicate the issue.
Event or Problem Description
A customer reported their lumify ultrasound system failed to complete the boot up process during a trauma helicopter flight due to improper use of the device.The customer had to restart the lumify device more than 5 times.The delay caused by the multiple restarts is alleged to have resulted in delay and suboptimal care due to the ultrasound being unavailable.It is unclear whether the lumify system was used to provide ultrasound images.The patient was in critical trauma condition which is a life-threatening situation but ultimately survived.The patient required medical intervention, but the intervention type was not provided.

• Brand Name: LUMIFY
• 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: 20428606
• Report Number: 3019216-2024-00145
• Device Sequence Number: 18247733
• Product Code: IYN
• UDI-Device Identifier: 00884838064713
• UDI-Public: 00884838064713
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 795005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/11/2024
• 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