MAUDE Adverse Event Report: ELEKTA, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problems Disconnection (1171); Computer System Security Problem (2899)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Patient was in middle of treatment and mosaiq, the record and verify system, was disconnected.We were soon notified the elekta cloud was pulled offline due to potential compromise to their system.All patients from 3pm on have been canceled and will be rescheduled once we are made aware that mosaiq is back online.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA, INC.; 400 perimeter center terrance ne suite 50; atlanta GA 30346
• MDR Report Key: 11744319
• MDR Text Key: 247944793
• Report Number: 11744319
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2021

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA