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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).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 their sparq ultrasound system failed while in the emergency room.The touch panel became unresponsive immediately after turning the system on to perform a diagnosis.The doctor was unable to diagnose the patient until another ultrasound system arrived.This delayed the doctor¿s diagnosis for 30 minutes and the patient ultimately expired.
Additional Manufacturer Narrative
The ultrasound system was tested at the customer site by the philips service engineer and no problem was found.A thorough investigation was performed to identify the root cause of this issue, including an evaluation and analysis of the logs from the ultrasound system.The software engineering team was unable to reproduce the issue during testing which made identifying the root cause not possible.The system is still in service with no additional similar issues reported.The customer has acknowledged the ultrasound system did not cause or contribute to the patient¿s outcome.
Event or Problem Description
A customer reported their sparq ultrasound system failed while in the emergency room.The touch panel became unresponsive immediately after turning the system on to perform a diagnosis.The doctor was unable to diagnose the patient until another ultrasound system arrived.This delayed the doctor¿s diagnosis for 30 minutes and the patient ultimately expired.

• 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: 11638467
• Report Number: 3019216-2021-10044
• Device Sequence Number: 3356117
• Product Code: IYN
• UDI-Device Identifier: 00884838097971
• UDI-Public: 00884838097971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Distributor Facility Aware Date: 04/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 04/04/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male