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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the epiq ultrasound system control panel was swiveling and not locking.It is unknown if the issue was discovered during transport.There was no injury or clinical use associated with this event.A philips service engineer cleaned and adjusted pin and solenoid.The system was put back into service with no additional issues reported post repair.
Additional Manufacturer Narrative
Additional information had been obtained and it was confirmed by the field service engineer that the ultrasound system was stationery at the time this event occurred.This product malfunction is considered to be a non-reportable event since there is no evidence to suggest a reportable event has occurred.
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: EPIQ ELITE
• 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: 18186054
• Report Number: 3019216-2023-00167
• Device Sequence Number: 20649175
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: 00884838099111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200304
• 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,Followup,Followup
• Report Date (Section B): 09/06/2024

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: EPIQ ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 10/27/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/20/2023; 09/06/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown