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

Model Number EPIQ 7C ULTRASOUND SYSTEM

Device Problem Unintended System Motion (1430)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

A thorough investigation was performed which included an engineering evaluation of the swivel mechanism bushing moving out of position.The displaced bushing prevented the control panel from locking properly.The philips field service engineer applied adhesive and reseated the bushing to resolve the issue.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

The customer reported the swivel mechanism of their epiq ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.No patient or user was harmed as a result of the issue.The ultrasound system has been returned to service with no additional issues reported.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the failure was caused by a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.Additional actions to prevent this failure from occurring are underway.

• Brand Name: EPIQ 7
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 11351447
• MDR Text Key: 233475118
• Report Number: 3019216-2021-10021
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7C ULTRASOUND SYSTEM
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2016
• 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