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

Model Number 989605386721

Device Problem Output Problem (3005)

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

Event Date 08/19/2021

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

A customer reported an l18-5 transducer used with an epiq 7g ultrasound system was producing an artifact in 2d mode during a biopsy procedure.However, the procedure in progress was completed successfully using the same system and transducer.There was no patient or user harm associated with this event.

Manufacturer Narrative

The engineering team was unable to determine the root cause of the reported failure as the probes that had been replaced were inadvertently disposed of.The customer remains using the l18-5 transducer but has also purchased an el18-4 transducer for better image on deep lesions.

• Brand Name: EPIQ 7G
• 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: 12485331
• MDR Text Key: 271903422
• Report Number: 3019216-2021-10125
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605386721
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2017
• 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