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

Lot Number US4191

Device Problems Inadequate User Interface (2958); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Philips sparq ultrasound machine not working.Buttons remain frozen with message that states "the system experienced an error and is collecting data.Please record the following information and contact your philips service representative.Diagnostic code (b)(6)." equipment tagged and sent to biomed for service.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 12287149
• MDR Text Key: 265367271
• Report Number: 12287149
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2021,06/29/2021

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
• Device Operator: No Information
• Device Lot Number: US4191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2021
• Date Report to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1