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	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility medsun (# (b)(4) ) was received reporting the following: during cardiac surgery, transesophageal echocardiogram (tee) machine worked for initial exam.Subsequently the echo image froze and anesthesiologist was unable to complete echo.Steps taken to restart machine unsuccessful.New tee machine obtained from heart station.It is unknown what surgery was performed.No patient harm was reported.The reported indicated that a product problem occurred.It is unknown if the procedure was completed, the medsun documented a new tee machine was obtained from the heart station.Although multiple attempts were made, no further information was received from the customer.If further information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The investigation concluded the x8-2t transducer¿s connector had burnt pins from fluid ingress.This is a sign of a maintenance issue.

• 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: 20054449
• Report Number: 3019216-2024-00118
• Device Sequence Number: 7955431
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 73 YR
• Patient Sex: Unknown