MAUDE Adverse Event Report: PHILIPS ULTRASOUND (SHANGHAI) CO., LTD. PHILIPS EPIQ CVX 3D ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number EPIQ ELITE

Patient Problem Electric Shock (2554)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

Employee was reviewing images on the philips epiq ultrasound system.When she pressed the "acquire" button all of the buttons lit up on the machine which is not normal functionality.She felt a shock in her finger and it ran through her right hand.She could not lift her finger off of the acquire button as a result of the shock until the image was finished acquiring (about 3-4 seconds) employee reported a tingling sensation in her hand for a short period of time after the shock.The machine was immediately taken out of service.The biomedical department was called to evaluate.Philips was then contacted for a technician to evaluate.Philips technician inspected the machine and stated that all of the machine's components checked out as safe to use.The recommendation from philips was to get a new control panel and install a static chain to prevent any incidents of electrical shock from happening in the future.The technician stated there have been reports about static shock and possible electrical shock from the ultrasound probe, but not from the control panel.The machine remains quarantined out of service until replacement parts are available.

• Brand Name: PHILIPS EPIQ CVX 3D ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND (SHANGHAI) CO., LTD.
• MDR Report Key: 18493816
• MDR Text Key: 332904891
• Report Number: MW5150137
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2024

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
• Device Operator: Health Professional
• Device Model Number: EPIQ ELITE
• Device Catalogue Number: NNAP990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1