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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem No Device Output (1435)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Return of the suspect acquisition module is anticipated.Evaluation of the 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 shut down during a watchman study.The study in progress was completed successfully after rebooting the ultrasound system.A philips service engineer replaced the acquisition module to repair the system.There was no patient or user harm associated with this event.

• Brand Name: EPIQ 7C
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12565502
• MDR Text Key: 274447545
• Report Number: 3019216-2021-10127
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2016
• 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