MAUDE Adverse Event Report: EXA; SOFTWARE EXA PACS

Model Number	UE00N59
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation concluded that the network connection on the radiologist's computer is substandard for the use of viewing diagnostic images in a timely manner.Due to the long content download times, it was recommended that the radiologist wait until that series is mostly downloaded (identified with a green bar) before scrolling through the series with a mouse wheel.Manufacturer identified that when user pressess the up/down/left/right arrow keys to advance frames, the issue is not present.Supplemental report will be filed upon receipt of new and/or relevant information.
Event or Problem Description
Customer reported frame skipping issues when playing cine series.The radiologist recently missed a brain bleed on a patient which caused a negative outcome, but did not result in death.The brain bleed apparently showed on only one image and it was the image that was skipped.Information reported indicates a reportable malfunction data display issue (non-image quality), which may cause or contribute to a serious injury requiring medical intervention; therefore, a reportable malfunction will be filed.

• Brand Name: EXA
• Common Device Name: SOFTWARE EXA PACS
• MDR Report Key: 10820482
• Report Number: 1064396-2020-00001
• Device Sequence Number: 19774501
• Product Code: LLZ
• UDI-Device Identifier: 00817100020193
• UDI-Public: 00817100020193
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142919
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: UE00N59
• Device Catalogue Number: UE00N59
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/10/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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