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

Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineer performed diagnostic and electrical safety tests on the system which passed.The x8-2t transducer was physically inspected and image quality tested which passed.Further investigation revealed the transducer connector was wet when the user attempted to plug it into the system which caused the electrical arc and system shutdown.As all visual, diagnostic, and electrical safety tests passed, the transducer was retained by the customer and returned to service.A return of the transducer is not anticipated, therefore, no further root cause analysis can be performed.

Event Description

The customer reported an electrical arc was visible when connecting an x8-2t model transducer to their epiq cvx ultrasound system prior to an examination.No patient or user was harmed as a result of the issue.

• Brand Name: EPIQ CVX
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12251897
• MDR Text Key: 264270650
• Report Number: 3019216-2021-10092
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097933
• UDI-Public: (01)00884838097933
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/14/2021
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1