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

Model Number EPIQ CVX DIAGNOSTIC ULTRAOSUND SYSTEM

Device Problems Operating System Becomes Nonfunctional (2996); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Event Description

The customer reported an incident where their epiq ultrasound system displayed an error message that required a system restart to recover.The error occurred 3 times during a mitral clip procedure while using an x7-2t model transducer.There was no allegation of patient or user harm as a result of the issue.However, the issue caused a 20 minute delay in the procedure.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of this issue, including an evaluation and analysis of the logs from the ultrasound system and customer workflow.The software engineering team could not reproduce the issue as described by the customer.However, the reported error message indicates the displayed values being out of system parameter limits, and not the actual value used by the system.A philips applications specialist went to the customer site with a workflow workaround and no additional issues were observed during onsite testing and monitoring.The system has been placed back into service with no additional complaints regarding this issue reported by the customer post resolution.

Event Description

The customer reported an incident where their epiq ultrasound system displayed an error message that required a system restart to recover.The error occurred 3 times during a mitral clip procedure while using an x7-2t model transducer.There was no allegation of patient or user harm as a result of the issue.However, the issue caused a 20 minute delay in the procedure.

• Brand Name: EPIQ CVX
• Type of Device: 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 11346318
• MDR Text Key: 232538864
• Report Number: 3019216-2021-10020
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ CVX DIAGNOSTIC ULTRAOSUND SYSTEM
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• 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