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

Model Number 989605488741

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

A customer reported the swivel mechanism of their epiq cvx 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

H10: the philips field service engineer (fse) replaced the suspected parts to resolve the reported issue.Improvements to the articulating display arm and bolt have been implemented to mitigate this issue, as well as newly revised service parts are also available.H11: initially the event was reported in the b5, ¿a customer reported the swivel mechanism of their epiq cvx 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.¿ this was incorrect and should have been reported, ¿a customer reported the monitor was loose.The field service engineer (fse) clarified the failure to include the monitor arm came apart.The articulation arm and the display were replaced.No patient or user was harmed as a result of the issue.¿.

• Brand Name: EPIQ CVX
• 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15590873
• MDR Text Key: 304528754
• Report Number: 3019216-2022-00088
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1320304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605488741
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1