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

Model Number	SPARQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
A customer reported encountering an incident with their sparq ultrasound system during a surgical procedure.While performing a live transabdominal image scan for a dilation and curettage (d&c) with hysteroscopy procedure, the system locked up and could not be restarted.The patient needed to be sent by ambulance to another facility to complete the procedure.The procedure was completed successfully with no adverse outcome to the patient.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information able to be obtained, the engineering team was unable to determine the root cause of this failure.The system software was reloaded to resolve the issue for the customer and no additional similar issues have been reported since this repair.
Event or Problem Description
A customer reported encountering an incident with their sparq ultrasound system during a surgical procedure.While performing a live transabdominal image scan for a dilation and curettage (d&c) with hysteroscopy procedure, the system locked up and could not be restarted.The patient needed to be sent by ambulance to another facility to complete the procedure.The procedure was completed successfully with no adverse outcome to the patient.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Common Device Name: 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: 11785588
• Report Number: 3019216-2021-10055
• Device Sequence Number: 921902
• Product Code: IYN
• UDI-Device Identifier: 00884838028098
• UDI-Public: 00884838028098
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• 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: SPARQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2019
• 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: Female