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

Model Number BM431

Device Problem No Device Output (1435)

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

Event Date 08/18/2021

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 epiq 7c ultrasound system did not have any imaging modes available during a follow up tee examination.The examination in progress was rescheduled and completed successfully using a different ultrasound system available at the customer site.A philips service engineer replaced the hard drives and reloaded the software to repair the system.There was no patient or user harm associated with this event.

Manufacturer Narrative

A philips field service engineer went to the customer site to retain the replaced hard drives and gather system logs for further investigation.However, the service engineer was unable to retrieve system logs since the hard drives containing the logs were corrupted.He was also unable to retain the replaced hard drives since they had already been disposed of prior to return.The lack of system logs and replaced hardware prevented additional investigation to determine the root cause of the issue.After re-installation of the system¿s software and replacement of the hard drives, the system was working as intended and passed all post repair testing.No additional complaints regarding this issue have been reported by the customer post repair.

Event Description

A customer reported an epiq 7c ultrasound system did not have any imaging modes available during a follow up tee examination.The examination in progress was rescheduled and completed successfully using a different ultrasound system available at the customer site.A philips service engineer replaced the hard drives and reloaded the software to repair the system.There was no patient or user harm associated with this event.

• Brand Name: EPIQ 7C ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 12471683
• MDR Text Key: 271478015
• Report Number: 3019216-2021-10120
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (y/n): Y
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM431
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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