MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 5 DS; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number EPIQ 5 DIAMOND SELECT

Device Problem Incorrect Measurement (1383)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Information has been received from the customer to begin the investigation.Additionally, a philips service engineer is scheduled to retrieve the system logs at the customer site.Evaluation of the logs and investigation results will be included in a follow up report upon completion.

Event Description

A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.

Manufacturer Narrative

A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.The manufacturer requested the system logs from the customer for evaluation.A thorough investigation was performed by development engineering who identified a difference between the customer¿s expectations and the calculations of the average values for umbilical artery, mca and duct venosus performed by the epiq system.The manufacturer concluded the device work as intended.The system is currently in use at the customer site with no additional similar issues reported.

Event Description

A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.

• Brand Name: EPIQ 5 DS
• 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: 13253381
• MDR Text Key: 286576226
• Report Number: 3019216-2022-00005
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097858
• UDI-Public: 00884838097858
• 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: 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: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 5 DIAMOND SELECT
• Device Catalogue Number: 795120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2021
• 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