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

Catalog Number 795200

Device Problem Incorrect Measurement (1383)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported the epiq 7g ultrasound system had recent software installed and during an echo, the customer wanted the radiology setting imported which overwrote the echo settings.The measurements and annotations were not correctly set up on the system.There was no missed / misdiagnose.There were measurements missing; however, the reporting system allowed the reading cardiologist to do them manually for the studies that were done.The measurements that were in the wrong place was also able to be fixed in syngo.This was not a system malfunction.The system was performing exactly as it was programmed.The system had been upgraded via a maximizer software update by engineer the previous day to this service call.The system was shared service and used between two different departments at the hospital.In the process of restoring backups from the two different other systems to get both radiology and cardiology settings onto this unit, the engineer inadvertently had overwrote and erased the cardiac analysis and annotations settings so that they actually were set to system defaults.The engineer resolved the issue the following day and had the customer verify that all their custom settings were restored.The echo was completed but had to be fixed with the reporting system syngo.Philips has started an investigation for this complaint.

Manufacturer Narrative

A thorough investigation found the system had been upgraded and in the process of restoring the system backup, the field service engineer inadvertently overwrote and erased the cardiac analysis and annotations settings.This was later corrected.It was verified there was no misdiagnosis or mix of patient data.The measurements that missing were able to be manually added by the reading cardiologist.The system did not malfunction.In order to avoid further similar issues, a software change request has been proposed to avoid when doing a software upgrade and restore, overwriting the system's main settings.This option is under consideration for a future program.

• Brand Name: EPIQ 7G
• 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: 16816384
• MDR Text Key: 314022384
• Report Number: 3019216-2023-00055
• Device Sequence Number: 1
• Product Code: IYN
• 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,Company Representative
• 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: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: 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