MAUDE Adverse Event Report: AFFINITI 50 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	989605410251
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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 encountering an incident where a patient¿s data was mixed with another exam.According to the case details, images from a previous study appeared in the next patient¿s exam.The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.
Additional Manufacturer Narrative
A philips field service engineer went to the customer site to gather system logs for further investigation.Evaluation of the system logs could not identify any system malfunction, and the system appeared to be working as designed.Additional information regarding this event was unable to be obtained from the customer and the reported issue could not be reproduced, so the root cause could not be determined.No additional events have been reported for this issue by the customer post notification.
Event or Problem Description
A customer reported encountering an incident where a patient¿s data was mixed with another exam.According to the case details, images from a previous study appeared in the next patient¿s exam.The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.

• Brand Name: AFFINITI 50 ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 11963249
• Report Number: 3019216-2021-10070
• Device Sequence Number: 4543939
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132304
• 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: 989605410251
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/19/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2015
• 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