MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	795087
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
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
The customer reported that intermittently, when transferring the study from their cx50 to a pen drive (usb), when the study is uploaded and printed from a computer, the report shows two patient names.When they restart the machine it issue is resolved.Also, when the report is printed directly from the cx50, the header and patient name are correct.There was no patient or user harm associated with this event.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.Their assessment concluded this has been resolved in a subsequent software release.The field service engineer has been advised and recommended to update the system software.

• Brand Name: CX50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16246911
• Report Number: 3019216-2023-00010
• Device Sequence Number: 17755637
• Product Code: IYN
• UDI-Device Identifier: 00884838097964
• UDI-Public: 00884838097964
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K123754
• 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: 795087
• Device Catalogue Number: 795087
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 05/28/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2019
• 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