MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 50 - 795208; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	989605410251
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Data provided by the customer is being analyzed.An investigation is underway to determine the root cause of the issue.
Event or Problem Description
A customer reported encountering an incident where a patient¿s data was mixed with another exam.According to the feedback details, an image 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
The investigation into the reported issue concluded there was no product malfunction.Additional information provided by the customer verified the event was caused by user error and no device malfunction occurred.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: AFFINITI 50 - 795208
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9297261
• Report Number: 3019216-2019-00078
• Device Sequence Number: 2341760
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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 Lot Number: US317D0766
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1