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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

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INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEPACS PICTURE ARCHIVING AND COMMUNICATION Back to Search Results
Model Number VERSIONS 4.5.1 AND UP
Device Problems Display or Visual Feedback Problem (1184); Loss of Data (2903); Data Problem (3196)
Patient Problem Misdiagnosis (2159)
Event Type  Malfunction  
Manufacturer Narrative

In order to correct this issue, intelerad will: provide the affected clients with a list of studies that were affected and possibly recover the missing images. Deploy a software update that includes a fix and mitigation to all clients where the issue could potentially occur. This will be done tentatively. Periodically audit all affected client, any new occurrences of this issue until the mitigation (software update) is in place. The software update will include only bug fixes - your workflow will not be affected. The update will result in about 5 minutes of downtime per server as we perform a full service restart. Impact on users will be minimal, if any. Corrective action calendar: for all clients with pacs version 4-5-1 or higher, the software update will be deployed within a timeframe to be agreed with clients (completion estimated by end of march 2016).

 
Event Description

No patient incident reported at this moment - this issue is documented as a precaution. Five related customer complaints ((b)(4)) were registered and investigated from oct 2014 to june 2015 for related issues. The investigation of these complaints led to the discovery of issues with image ingestion. Bugs identified: (b)(4) lds: lds: failed to ingest image with overlays belonging to 60xx group having alphanumeric id (ie, 600a) (b)(4) lds: rows stuck in incoming_files due to files missing in the incoming files folder. Investigation: investigation of the logs in (b)(4) revealed that some of the expected overlay files were not found on the file system; this led to discovery of the missing files left behind at an earlier stage of image ingestion. Root cause of the problem: due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process can lead to images not being visible to the end user. There is no indication to the user that this has occurred. Reason for possible patient safety: the radiologist may provide a diagnosis without being aware that images are missing. Design mitigation to reduce the risk: proposed new mitigation: the pacs will report problems ingesting images and indicate such issues to the user ((b)(4)). This mitigation will be included in a coming software release. (b)(4): lds: expose broken series to user (warn about additional images pending ingestion when viewing images). Detectability of problem: until the software update that will include the proposed mitigation is installed on the client's system, the user may not be aware that some images may be missing. However, if the client's system has other mechanisms to verify image count between source and destination, then the user might be able to know about the discrepancy.

 
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Brand NameINTELEPACS
Type of DevicePICTURE ARCHIVING AND COMMUNICATION
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEMS INCORPORATED
montreal quebec
CA
Manufacturer Contact
luce caron
895, de la gauchetiere west,ste 400
montreal quebec H3B 4-G1
CA   H3B 4G1
5149316222
MDR Report Key4960870
MDR Text Key24652689
Report Number9615916-2015-00002
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK083520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVERSIONS 4.5.1 AND UP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2012
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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