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

Model Number 989605488741

Device Problems No Device Output (1435); No Visual Prompts/Feedback (4021)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

A philips service engineer replaced the fan assembly to repair the system.The system has been placed back into service with no additional issues reported.An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Event Description

A customer reported an epiq cvx ultrasound system shut down during a cardiac catheterization and transesophageal echo (tee) procedure.The examination in progress was completed successfully using a different ultrasound system at the customer site.There was no patient or user harm associated with this event.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue.However, the engineering team was unable to find a definitive root cause or evidence of a systemic defect.The investigation concluded the failure was likely caused by a defective fan or dirty air filter on this particular system.The system air cooling fan assembly was replaced to resolve the issue for the customer and no additional similar issues have been reported since this repair.

Event Description

A customer reported an epiq cvx ultrasound system shut down during a cardiac catheterization and transesophageal echo (tee) procedure.The examination in progress was completed successfully using a different ultrasound system at the customer site.There was no patient or user harm associated with this event.

• 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: 12312295
• MDR Text Key: 266185054
• Report Number: 3019216-2021-10102
• 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: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Distributor Facility Aware Date: 07/27/2021
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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