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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Disconnection (1171); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

The mosaiq application froze and crashed/disconnected during radiation treatment and taking images.The radiation treatment delivered did not record and verify back to mosaiq.The cbct image did record.The patient received treatment as ordered, no harm to patient.Physics recorded the treatment delivered.It/is, manager, vendor and physics notified.

• 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: 10704052
• MDR Text Key: 212130470
• Report Number: 10704052
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MOSAIQ
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2020
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA