MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an x8-2t transducer would not consistently respond to the articulation dial during patient use.The transducer was being used with an epiq 7c ultrasound system.There was no patient or user harm associated with this event.The field service engineer evaluated the transducer and confirmed the angle buttons were not functioning as expected the image view stopped and went in reverse once.A recommendation to replace the transducer was provided to the customer.
Additional Manufacturer Narrative
A thorough investigation was to be performed to determine the root cause of the reported failure; however, the customer declined to return the probe for evaluation.No further information is available at this time to investigate the reported issue further.The system has returned to service with no similar issues reported.

• Brand Name: EPIQ 7
• 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: 19657695
• Report Number: 3019216-2024-00092
• Device Sequence Number: 15088185
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/25/2024

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 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2016
• 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