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

Model Number 989605386721

Device Problem Output Problem (3005)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Return of the suspect acquisition module is anticipated.Evaluation of the acquisition module will be included in a follow-up report upon its return and investigation completion.

Event Description

A customer reported an epiq 7c ultrasound system became unresponsive and displayed an error message during heart surgery.The examination in progress was completed successfully using a different ultrasound system available at the customer site.The acquisition module was replaced to repair the system.There was no patient or user harm associated with this event.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue, including a technical evaluation of the replaced components.The engineering team determined the reported intermittent issue resulted from a hardware component failure.The investigation determined an acquisition module can intermittently display an error code when exposed to a heat stress anomaly.Restarting the ultrasound system resolves the immediate issue.The philips service engineer replaced the acquisition module to resolve this issue for the customer and no additional similar events have been reported post system repair.

• Brand Name: EPIQ 7C
• 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: 12416081
• MDR Text Key: 278177588
• Report Number: 3019216-2021-10110
• 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: 09/02/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/13/2021
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2018
• 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