Model Number 989605408541 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/11/2022 |
Event Type
malfunction
|
Event Description
|
A customer reported the swivel mechanism of their epiq 5g ultrasound system¿s control panel did not lock properly while transporting the unit.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.
|
|
Manufacturer Narrative
|
Return of the suspect defective part is anticipated.Evaluation of the defective part will be included in a follow up report upon its return and investigation completion.
|
|
Manufacturer Narrative
|
A thorough investigation was performed to identify the root cause of the reported issue, including a manufacturing evaluation and analysis of the involved monitor arm.The engineering team determined the failure resulted from a shoulder bolt with the flats on both side which are responsible for stress concentration and failure.A design change to ergotron arm and a larger cross section of the fastener has been implemented to prevents potential recurrence of this assembly error.
|
|
Search Alerts/Recalls
|