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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INTELEPACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM
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INTELERAD MEDICAL SYSTEMS INTELEPACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM Back to Search Results
Model Number INTELEPACS 4-9-1 AND UP
Medical Device Problem Codes Failure to Back-Up (1047); Loss of Data (2903)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
N.A.
 
Event or Problem Description
A user reported that approximately 1000 studies were lost from the pacs storage and a referring physician was unable to view images.Radiologist reports for these deleted studies remained available.Preliminary analysis determined the problem is due to a configuration key that was activated in combination with a software bug.When the feature forceglobalstudydeletion is enabled, any series deletions that occur on a server are automatically elevated to a system-level study deletion.This system-level deletion bypasses existing mitigation policies (i.E., archive policies) on other servers.
 
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Brand Name
INTELEPACS
Common Device Name
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
MDR Report Key9751805
Report Number9615916-2020-00002
Device Sequence Number1828176
Product Code LLZ
UDI-Device IdentifierB228INTELEPACS0
UDI-PublicB228INTELEPACS0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K150707
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberINTELEPACS 4-9-1 AND UP
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/07/2020
Initial Report FDA Received Date02/25/2020
Patient Sequence Number1
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