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

Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Incorrect Measurement (1383)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

The customer reported deviating values during a specific measurement when using an epiq 7g ultrasound system: peak systolic velocities in tortuous iliac vessels in comparison with a terason tera 3000.The device was in clinical use.No patient or user was harmed.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

An investigation into this issue was performed and it was discovered that the customer settings were not used as designed.R&d reached out to the customer with a workaround.Customer is satisfied with the updated instructions.

Event Description

The customer reported deviating values during a specific measurement when using an epiq 7g ultrasound system: peak systolic velocities in tortuous iliac vessels in comparison with a terason tera 3000.The device was in clinical use.No patient or user was harmed.

• 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: 16467787
• MDR Text Key: 310634976
• Report Number: 3019216-2023-00025
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 795200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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