MAUDE Adverse Event Report: MERGE HEALTHCARE RADSUITE; IMAGE PROCESSING SYSTEM

Model Number 8.30.7

Device Problems Computer Software Problem (1112); Application Program Problem (2880)

Patient Problem Missing Value Reason (3192)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, tis issue was determined to be reportable as an mdr.

Event Description

A radsuite customer reported that when the radiologist is scrolling through the images in the viewer there have been delays of between 5 and 10 minutes.User error in setting up a custom macro and lack of verification of that macro resulted in this issue.This macro contains a persistable that needs to query the database everytime it is called on.When the user is scrolling thru images the macro is making a database call and needs to have the information from the database before it can go any further thus causing the viewport to "freeze" as it is waiting on the information from the database.Most of the time it is not a problem but there are times where there seems to be contention in the database or a network or storage issue that is causing a delay.(b)(4).

• Brand Name: RADSUITE
• Type of Device: IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437821
• MDR Text Key: 38218877
• Report Number: 2183926-2015-00139
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8.30.7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2013
• 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