MAUDE Adverse Event Report: ELEKTA LIMITED VERSA; ACCELERATOR, LINEAR, MEDICAL

Model Number VERSA

Device Problems Device Dislodged or Dislocated (2923); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2020

Event Type  malfunction  

Event Description

During treatment linear accelerator was getting temperature faults.After talking to the elekta engineer it was determined that there were flow issues and a chiller problem maintenance was called to inspect and powell mechanical came in.They discovered that a filter dislodged and was "sucked" into the pipe.He bypassed it and was notifying the project manager to determine if chiller was installed incorrectly.

• Brand Name: VERSA
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LIMITED; 400 perimeter center terrance ne suite 50; atlanta GA 30346
• MDR Report Key: 10669824
• MDR Text Key: 211029956
• Report Number: 10669824
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1