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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Unintended System Motion (1430)

Patient Problem Hyperextension (4523)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The philips field service engineer performed a system inspection and determined that the control panel arm¿s swivel lock bushing had risen out of place preventing a proper lock.The service engineer was able to reseat the bushing into the correct position to resolve the issue.As the system has been returned to service with no part return anticipated, no further failure analysis can be performed.

Event Description

The customer reported an incident where the swivel mechanism of their epiq ultrasound system¿s control panel would not lock properly while in transit.The cart was in motion when the lock failed, and the sudden unexpected motion of the control panel caused the user to experience a minor hyperextension to keep the cart under control.The user did not require medical attention as a result of the failure.

• Brand Name: EPIQ 7
• 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: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 11024023
• MDR Text Key: 225776568
• Report Number: 3019216-2020-00123
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• 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: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2020
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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