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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2020

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 evaluation determined the ultrasound system did not have loctite on the swivel mechanism bushing to prevent movement over time.The inclusion of applying loctite to the swivel mechanism bushing during assembly has been implemented to reduce the probability of future recurrence.

Event Description

The customer reported the swivel mechanism of their epiq 7c ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.The system was repaired by reseating the solenoid bushing into position.There was no injury to user or patient and the ultrasound system has been returned to service with no additional issues reported.

• 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: 10858742
• MDR Text Key: 217667303
• Report Number: 3019216-2020-00111
• 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

• 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: 11/02/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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