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

Model Number	989605394911
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
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 patient images were corrupted and mixed with different studies after exporting from their sparq ultrasound system to a usb drive.The images were correct on the system and the diagnosis was performed successfully.The issue was obvious to the user and there was no harm to the user or patient associated with this event.
Additional Manufacturer Narrative
A philips field service engineer went to the customer site to gather system data for further investigation.However, the customer had deleted the system database after exporting it to an external hard drive.The customer confirmed the external hard drive was corrupted and the original system data could no longer be retrieved.The exporting of data to a corrupted third party external drive was determined to be the root cause of the issue.There was no ultrasound system malfunction associated with this event.The system has been placed back into service with no additional complaints regarding this issue reported by the customer post notification.
Event or Problem Description
A customer reported patient images were corrupted and mixed with different studies after exporting from their sparq ultrasound system to a usb drive.The images were correct on the system and the diagnosis was performed successfully.The issue was obvious to the user and there was no harm to the user or patient associated with this event.

• 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: 13293654
• Report Number: 3019216-2022-00007
• Device Sequence Number: 4547442
• Product Code: IYN
• UDI-Device Identifier: 00884838028098
• UDI-Public: 00884838028098
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Biomedical Engineer
• 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: 989605394911
• Device Catalogue Number: 795090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2019
• 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: Unknown