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

Model Number 795231

Device Problem Unintended System Motion (1430)

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

Event Date 02/09/2023

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.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 philips service engineer replaced the articulation arm solenoid stator to repair the system.The suspect monitor arm assembly was not able to be returned to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.However, the ultrasound system has been returned to service with a replacement monitor arm with no similar issues reported.

Manufacturer Narrative

A philips service engineer replaced the articulation arm solenoid stator to repair the system.The suspect monitor arm assembly was not able to be returned to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.However, the ultrasound system has been returned to service with a replacement monitor arm with no similar issues reported.

• Brand Name: EPIQ CVX
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16418498
• MDR Text Key: 310104581
• Report Number: 3019216-2023-00021
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838107526
• UDI-Public: 00884838107526
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795231
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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