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

Model Number INTELEPACS 4-9-1 AND UP

Device Problems Failure to Back-Up (1047); Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

N.A.

Event 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.

• Brand Name: INTELEPACS
• 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: luce caron ; 800, boul. de maisonneuve e.; 12th floor; montreal, quebec H2L 4-L8 ; CA H2L 4L8
• MDR Report Key: 9751805
• MDR Text Key: 221577093
• Report Number: 9615916-2020-00002
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELEPACS 4-9-1 AND UP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1