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

Model Number	SPARQ ULTRASOUND SYSTEM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the x7-2t tee transducer would not articulate during use with an epiq 7c ultrasound system.There was no patient or user harm associated with this event.It is unknown if the exam was completed.A quote for a replacement was provided.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.
Additional Manufacturer Narrative
The customer declined service and support to replace the suspect transducer.As a result, the transducer remains at the customer site and could not be returned for failure analysis.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Common Device Name: SYSTEM,IMAGING,PULSEDDOPPLER,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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20609572
• Report Number: 3019216-2024-00155
• Device Sequence Number: 20666868
• Product Code: IYN
• UDI-Device Identifier: 00884838028098
• UDI-Public: 00884838028098
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K091804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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 ULTRASOUND SYSTEM
• Device Catalogue Number: 795090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown