MAUDE Adverse Event Report: PHILIPS ULTRASOUND SPARQ ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	989605394911
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial review of the suspect ultrasound system¿s data logs did not indicate a hardware failure.A philips service engineer is scheduled to visit the customer site to troubleshoot the cause of the reported failure.Results from the event evaluation and system repair will be included in a follow up report upon investigation completion.
Event or Problem Description
A customer reported their sparq ultrasound system locked up and displayed vertical line artifacts during transesophageal transducer use for exploratory surgery.The procedure was able to continue without the sparq system using the images previously acquired.There was no patient injury associated with this event.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue, including a technical and workflow evaluation of this event.The engineering team was unable to reproduce the issue as described by the customer.The system is currently in use at the customer site with no additional similar issues reported.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, 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: 14103428
• Report Number: 3019216-2022-00046
• Device Sequence Number: 4676862
• Product Code: IYN
• UDI-Device Identifier: 00884838028098
• UDI-Public: 00884838028098
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989605394911
• Device Catalogue Number: 795090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown