Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEVIEWER; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEVIEWER; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number VERSION 4-17-1-P480
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Potential harm with software; i work for the department of (b)(6).Our radiology pacs is supplied by intelerad medical systems.In the past, a code defect was identified that allowed our radiologists to dictate a radiology report on a study that had already been read by a local radiologist.The problem has returned and has resulted in conflicting reports and callbacks to ordering providers for critical results, with results that differed from the local radiologist report, leading to confusion on the part of the ordering provider.This software deficiency could result in a differing diagnosis and/or change in treatment plans if the local radiologist report differs significantly from the (b)(6) radiology report.Since this is now the second time that this problem has occurred and is a patient safety issue, i am elevating this to the fda.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELEVIEWER
Type of Device
SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEMS INCORPORATED
MDR Report Key10967085
MDR Text Key220428583
Report NumberMW5098239
Device Sequence Number1
Product Code LLZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVERSION 4-17-1-P480
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
-
-