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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/11/2022

Event Type  malfunction  

Event Description

The customer reported their epiq 7c ultrasound system displayed an error during an unspecified surgical procedure, when selecting the x8-2t transducer.The procedure was completed by using another ultrasound system and probe.No patient or user was harmed as a result of the issue.The field service engineer replaced the x8-2t transducer.

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.

Manufacturer Narrative

Evaluation of the transducer found the connector was exposed to fluid contamination that resulted in pin contamination/shorting.Confirmation of cause related to the fluid contamination of the connector pin field and is indicative of improper maintenance.H11: initially the health impact grid reflected no patient involvement; however, it should reflect: additional device required.

• Brand Name: EPIQ 7
• Type of Device: 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: 15916440
• MDR Text Key: 307993381
• Report Number: 3019216-2022-00109
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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