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

Model Number INTELEVIEWER 4-17-1 AND UP

Device Problems No Apparent Adverse Event (3189); Patient Data Problem (3197); No Visual Prompts/Feedback (4021)

Patient Problem Misdiagnosis (2159)

Event Type  malfunction  

Manufacturer Narrative

N.A.

Event Description

Following internal testing, intelerad has detected a problem that could occur on intelepacs software (inteleviewer module) and, providing additional information regarding this problem.Description of the problem: when the user has opened multiple orders in inteleviewer to dictate for different patients, and switches rapidly (subsecond) between them many times, it is possible for the viewer to display images from one patient while showing the patient record tab and dictation system for another.If the user takes any action in the viewer (including window focus), the views (images and dictation) will resynchronize with the patient record tab.This desynchronization situation can also arise when using a 3rd party dictation system, if the radiologist switches to the image viewing windows of a different patient using the operating system and does not interact at all with the viewer, while inteleviewer is waiting for the dictation system to complete a previous switch from one patient to another.Again, if the user takes any action in the viewer (including window focus), all of the views will resynchronize.Root cause analysis: the current issue (ip-107498) was introduced by the code change performed in order to fix issue (ip-95342).The change affected the way that inteleviewer handles switching between patients and introduced an edge case when the viewer can display images from one patient while showing the patient record tab and dictation system for another patient.By switching rapidly (subsecond) between patient record tabs without interacting with the viewer or selecting the image viewing window through the operating system while inteleviewer is waiting for the dictation system to complete a previous switch from one patient to another the viewer can end up in a state when it displays a different patient than the patient record tab and/or the dictation system.This code change was introduced in inteleviewer 4-17-1-r1 and does not affect earlier versions.Affected software versions: inteleviewer 4-17-1 r1 to r40.Inteleviewer 4-18-1 r1 to r17.Risk assessment: description of hazardous situation in use of the device: when the user has opened multiple orders to dictate for different patients, and switches rapidly (subsecond) between them many times, it is possible for the viewer to display images from one patient while showing the patient record tab and dictation system for another patient.If the user takes any action in the viewer (including window focus), the views (images and dictation) will synchronize.However, if the user dictates a report for the exam without subsequently touching the image viewer, then it is possible for the user to be viewing images from another patient when dictating the report.This situation can also arise if the user selects the image viewing window through the operating system while inteleviewer is waiting for the dictation system to complete a previous switch from one patient to another.Is this problem currently documented as a known risk? [x] yes [ ] no.Is there currently a mitigation in place to reduce this risk? [ ] no [x] yes.Has the mitigation worked to prevent risk to patient? [x] yes [ ] no.Can this risk be further reduced? design factors that might mitigate risk: mechanism to validate that image viewing window and patient record tab are properly synchronized after updating has stabilized probability of risk before mitigation? occasional: may occur from time to time in particular cases.Probability of risk after mitigation? very infrequent, but possible if multiple point failures occur.Severity of risk? potential misdiagnosis leading to possible injury requiring treatment.Detectability (user awareness.If device failure occurs, is it easily recognized by user) display of patient information.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 occur? the problem has not been reported by any of our clients; it was only discovered through internal testing.How often can the problem cause direct harm to the patient? the problem cannot cause direct harm to the patient.How often can the problem cause indirect harm to the patient? [see probability of risk after mitigation].Describe the factors that may contribute to product risk to the patient: very specific unusual interaction with the user interface.Factors that may contribute to product risk (i.E.Device design, manufacturing problems, or use error): as above.Function: viewer display: failure mode/defect: desynchronization between patient record tab and viewer.Local effect: misleading display.System effect: none.Adverse health consequences: potential misdiagnosis.Severity: injury requiring treatment (3 out of 5).Probability: very infrequent (2 out of 5).Risk rating: medium.Corrective action: in order to correct this problem: intelerad will inform all clients whose system has the affected software versions through a change requests in its service portal to track and to schedule the software update required for each client system.Intelerad will deploy a software update that includes a fix for all clients potentially affected by the problem (4-17-1 and up).Update of clients' end-users' workstations will be the responsibility of the client.Corrective action calendar: correction of the software: end of january 2020.Software update of affected clients' systems: end of (b)(6) 2020.

• Brand Name: INTELEPACS (INTELEVIEWER)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): INTELERAD MEDICAL SYSTEMS; 800, boul. de maisonneuve e.; 12th floor; montreal, quebec H2L 4 L8; CA H2L 4L8
• Manufacturer (Section G): INTELERAD MEDICAL SYSTEMS; 800, boul. de maisonneuve e.; 12th floor; montreal, quebec H2L 4 L8; CA H2L 4L8
• Manufacturer Contact: lauren bocquet ; 800, boul. de maisonneuve e.; 12th floor; montreal, quebec H2L 4-L8 ; CA H2L 4L8
• MDR Report Key: 9611265
• MDR Text Key: 221301692
• Report Number: 9615916-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELEVIEWER 4-17-1 AND UP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1