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U.S. Department of Health and Human Services

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

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INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEPACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM Back to Search Results
Model Number INTELEPACS 4-1-1 AND UP
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Misdiagnosis (2159)
Event Type  Malfunction  
Event Description

Intelerad has been made aware of a problem which could be a possible patient safety: the issue is triggered by the presence of the less than character (<) in the report. When viewing a report, the less than character is not present while it was there in the original report received by intelepacs. In other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports. No patient was reported impacted by the problem. This report is submitted preventively. Ticket case associated: (b)(4). Investigation details is documented in (b)(4): in inteleviewer, when viewing a report containing the less than (<) character which is not properly formatted for html, the symbol will not be displayed. This can change the meaning of the report. Root cause: when plain text reports are received from an external source, escaping of html characters should be performed. This behaviour is controlled by configuration that was not set correctly for this integration. Categories of reports: intelepacs can receive reports from multiple sources. As such, the reports can be stored in three different categories: html reports generated by intelerad - for this category, the less than character is visible in the reports as expected by the user. Html reports from external sources - these reports depend on the html formatting provided by the external source. If you are affected by this category, you should proceed with a review of configurations of the external source. Plain text reports from external sources that have been modified to be compatible with html - the reports associated with this problem are from this category. Risk assessment: description of hazardous situation in use of the device: · when viewing a report, the less than, i. E. "<" character, is not present while it was there in the original report. In other cases, parts of report text following the less than character are not displayed. · in both scenarios, there is a risk of misdiagnosis. Is this problem currently documented as a known risk? · yes. Is there currently a mitigation in place to reduce this risk? yes/no · yes. If yes, has the mitigation worked to prevent risk to patient? yes/no · no. The mitigation applied to a different category of report transformation. Can this risk be further reduced? design factors that might mitigate risk: · yes. Ensure applications that retrieve reports for rendering automatically detect and correct unescaped html. Probability of risk? before/after mitigation · before mitigation: remote probability because it requires missing configuration for escaping html, the mis-rendering having clinical significance and the absence of the affected text not being evident to exhibit the behavior. Severity of risk? before/after mitigation · before mitigation: potential misdiagnosis leading to possible injury requiring treatment. Detectability (user awareness. If device failure occurs, is it easily recognized by user) · depending on the positioning of the corruption within the text, it may not be readily detectable by a trained user. Risk vs. Benefit comparison (to help determine the recall strategy and type of the recall) · benefit of an increase in average time savings, diagnostic accuracy, data integrity and image accessibility outweighs the risk of low probability events leading to incorrect diagnosis. How often does the problem occurs? how often can the problem cause direct or indirect harm to the patient? · <1% of all the reports, including migrated prior reports. There have been no reported incidents of harm to patient in more than 15 years. This represents over 500 million reports. Describe the factors that may contribute to product risk to the patient · misconfiguration of interface. · use of incorrectly formatted report text. Factors that may contribute to product risk (i. E. Device design, manufacturing problems, or use error) · as above. (b)(6). Rationale and recommended actions: · adjusting the configuration for inbound reports will ensure that all new reports are not affected by this issue. Rolling out an intelepacs software update will ensure that all prior reports affected by this issue will display correctly. Proposed corrective actions: intelerad will: inform all clients of the issue. Verify configuration of report inbound channels at all client sites and apply correction if needed. The configuration should catch and escape the less than character ("<") in text reports. Provide all clients a fixed version of the device with an intelepacs software update. Versions 4-1-1 and 4-2-1 are no longer supported and will not be updated. Corrective action calendar: for the configuration review and change, intelerad requires a formal approval from the clients. The time to complete this corrective action therefore totally depends on if and when the client responds to the change request. For the software update, intelerad requires a formal approval from the clients and agree on a schedule for the upgrade. The time to complete the corrective action therefore totally depends on if and when the client responds to the software upgrade request. Affected versions: the intelepacs system is potentially affected if the version "r" identifier has a number below the following: pacs 4-1-1 r28, pacs 4-3-1 r49, pacs 4-3-2 r11, pacs 4-3-4 r39, pacs 4-6-1 r107, pacs 4-8-1 r65, pacs 4-9-1 r33, pacs 4-10-1 r61, pacs 4-11-1 r58, pacs 4-12-1 r45, pacs 4-14-1 r24, pacs 4-15-1 r7.

 
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Brand NameINTELEPACS
Type of DevicePICTURE ARCHIVING AND COMMUNICATION SYSTEM
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEMS INCORPORATED
895 de la gauchetiere st. 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 st. west
suite 400
montreal, quebec H3B 4-G1
CA   H3B 4G1
MDR Report Key7072814
MDR Text Key94400618
Report Number9615916-2017-00002
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberINTELEPACS 4-1-1 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 Received09/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2010
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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