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

Model Number EPIQ ELITE ULTRASOUND SYSTEM

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

The customer reported a thyroid mass appeared cystic on their epiq ultrasound machines.No patient or user was harmed as a result of the issue.An investigation is underway to determine the root cause of the issue.A follow up report will be provided upon investigation completion.

Manufacturer Narrative

The manufacturer previously reported the epiq elite ultrasound system a thyroid mass appeared cystic.No patient or user was harmed as a result of the issue.Multiple attempts to have additional information, images, and type of probe used were unsuccessful.The manufacturer believes they will be unable to gather any further information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: EPIQ ELITE
• 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: 15986352
• MDR Text Key: 308138368
• Report Number: 3019216-2022-00115
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• Is the Reporter a Health Professional?: No
• Type of Device Usage: A
• Patient Sequence Number: 1