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

Model Number SPARQ DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 04/16/2021

Event Type  malfunction  

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 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.

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 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
• 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: 11785588
• MDR Text Key: 250391611
• Report Number: 3019216-2021-10055
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838028098
• UDI-Public: 00884838028098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091804
• 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: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• 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
• Patient Sex: Female