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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEM INCORPORATED INTELEPACS INTELEVIEWER SYSTEM, IMAGE PROCESSING RADIOLOGICAL

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INTELERAD MEDICAL SYSTEM INCORPORATED INTELEPACS INTELEVIEWER SYSTEM, IMAGE PROCESSING RADIOLOGICAL Back to Search Results
Model Number 4.9.1
Device Problem Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2019
Event Type  Injury  
Event Description
Pacs application fails to identify that an external radiology report has been received and permits a radiologist to continue dictating a case that has been already finalized. This allows the discrepant reports to exist (1 internal to our pacs and 1 from the local radiologist who has their report entered into the permanent medical record). The locally generated report is not archived in pacs and any subsequent review of the case as a prior or for qa purposes, will have conclusions based on the internally generated report which is not the report of record.
 
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Brand NameINTELEPACS INTELEVIEWER
Type of DeviceSYSTEM, IMAGE PROCESSING RADIOLOGICAL
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEM INCORPORATED
215 e university dr
denton TX 76209
MDR Report Key8388184
MDR Text Key137865168
Report NumberMW5084611
Device Sequence Number0
Product Code LLZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4.9.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/04/2019 Patient Sequence Number: 1
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