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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 4.7.1 R27 AND UP, 4.8.1 R20 AND UP, 4.9.1 R17 AND UP, 4.10.1 R9 AND UP, 4.11.1 R
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Misdiagnosis (2159)
Event Type  Malfunction  
Event Description

No patient incident reported at this moment, this issue is documented as a precaution. The issue was reported by our client. They provide teleradiology services to various hospitals. Their protocol for accepting stat cases from these hospitals requires that the sending facility transmit a separate text message that identifies each stat case by accession no, together with the study description and the expected number of images to be transmitted. Further, based on this protocol, the client's administrative staff who control the workflow, confirms the image count transmitted is the same as the image count at the reading ctr (in intelepacs) before accepting the case and assigning to a radiologist for reading. Description of problem: images successfully transmitted to intelepacs are not available for reading in all studies, and the reader is unaware of the possibility of missing images. The problem manifests under very specific circumstances, limited to a few client sites as a possible patient safety issue. The possible patient safety arises when receiving a series and can manifest in two scenarios: first: for the 4 clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to deliver all received images to the permanent storage servers and no record of these images persist in the main archive. As these ingest servers are not configured as valid image locations for access by diagnostic viewers, the study can be displayed in intelepacs with less than full set of transmitted images. Second: for the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure (far less likely than the first scenario) for the device to properly replicate and register images when transferring them to another server. If the second copy is a valid image location, it is possible for a some images to be missing when viewing. We will: immediately verify and apply a bug fix to all the clients where this issue can occur; apply audit scripts to identify any occurrence of the issue and also validate the bug fix. Corrective action calendar: for the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the client specific release process (completed as of 04/23/2015) to avoid the possibility of data loss. For the remaining clients, the normal full release update (fru) will be expedited but undergo the usual testing and release process.

 
Manufacturer Narrative

Affected software versions: models: 4. 7. 1 r27 and up, 4. 8. 1 r20 and up, 4. 9. 1 r17 and up, 4. 10. 1 r9 and up, 4. 11. 1 r3 and up.

 
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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,
suite 400
montreal, quebec H3B 4-G1
CA   H3B 4G1
5149316222
MDR Report Key4763447
MDR Text Key5776251
Report Number9615916-2015-00001
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4.7.1 R27 AND UP, 4.8.1 R20 AND UP, 4.9.1 R17 AND UP, 4.10.1 R9 AND UP, 4.11.1 R
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2015
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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