MAUDE Adverse Event Report: KONICA MINOLTA HEALTHCARE AMERICAS, INC EXA; SOFTWARE EXA PACS

Model Number UE00N59

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Brain Injury (2219)

Event Date 10/09/2020

Event Type  malfunction  

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 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
• Type of Device: SOFTWARE EXA PACS
• Manufacturer (Section D): KONICA MINOLTA HEALTHCARE AMERICAS, INC; 2217 us highway 70 east; garner NC 27529
• MDR Report Key: 10820482
• MDR Text Key: 229631355
• Report Number: 1064396-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00817100020193
• UDI-Public: 00817100020193
• Combination Product (y/n): N
• PMA/PMN Number: K142919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UE00N59
• Device Catalogue Number: UE00N59
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1