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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEPACS (INTELEVIEWER) PICTURE ARCHIVING AND COMMUNICATION SYSTEM

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INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEPACS (INTELEVIEWER) PICTURE ARCHIVING AND COMMUNICATION SYSTEM Back to Search Results
Model Number IV 3-5-1 AND UP
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Event Description

No patient incident reported at this moment - this issue is documented as a precaution. Context: intelerad has identified a software problem with the magnification glass tool which, in some instances, displays a different image than the one currently being shown in the selected viewport. It appears that the tool is displaying a magnified image for a different slice of the series. This could potentially delay a diagnosis. This problem was reported by an intelerad employee while at a client site. Investigation: (b)(4). The sorting order of an image stack is not taken into account by the magnification glass tool. If the user is using reverse ordering (either manually selected or through a preference in the case of tomosynthesis) and then uses the magnification glass tool, the image shown in the tool will not be the one in the current viewport but rather the corresponding position from the opposite end of the stack. This defect applies to any modality with a stack of images, ex. Tomosynthesis, ct. The discrepancy is highly detectable by user and is extremely unlikely to lead to harm to the patient. Description of hazardous situation in use of the device: incorrect image being shown while using the magnification tool, which could cause a low possibility of delay in treatment. The incorrect images displayed are highly evident to radiologists. This problem is not currently documented as a known risk. A mitigation is currently in place to reduce this risk and to prevent risk to patient. The risk can be further reduced through additional internal software checks to prevent incorrect image display when inconsistencies are detected. Probability of risk: remote (2) severity of risk: improbable (1) detectability (user awareness. If device failure occurs, is it easily recognized by user): highly detectable by user. Risk vs. Benefit comparison: benefit of an increase in average time savings, diagnostic accuracy, data integrity and image accessibility outweighs the risk of low probability events leading to delayed diagnosis. The problem is only caused in multi image situations where the stack order is reversed and the magnification glass tool is used. The software failure is very evident and extremely unlikely to lead to harm to patient. The feature has been in use for eight years with only a single reported problem, with no indication of real harm. Corrective actions: intelerad will: 1) identify all clients affected (19 september 2017). 2) inform all concerned clients of the issue (september 2017). 3) provide all clients with a software upgrade (installation date as agreed with clients). Estimated completion date of the proposed recall action is june 2018.

 
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Brand NameINTELEPACS (INTELEVIEWER)
Type of DevicePICTURE ARCHIVING AND COMMUNICATION SYSTEM
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEMS INCORPORATED
895 de la gauchetiere west
suite 400
montreal, quebec H3B 4 G1
CA H3B 4G1
Manufacturer (Section G)
INTELERAD MEDICAL SYSTEMS INCORPORATED
895 de la gauchetiere st. west
suite 400
montreal, quebec H3B 4 G1
CA H3B 4G1
Manufacturer Contact
luce caron
895 de la gauchetiere west
suite 400
montreal, quebec H3B 4-G1
CA   H3B 4G1
MDR Report Key6901432
MDR Text Key88157813
Report Number9615916-2017-00001
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK150707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIV 3-5-1 AND UP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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