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

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

Elekta have raised an internal case to assess the risk of crosswire screen flammability on all beam limiting devices.

Manufacturer Narrative

H10 updated.29 april 2021 an initial report was previously submitted as 9617016-2021-00000 due to an administration error.This was rectified by submitting a corrected report on 29 april 2021 and the correct mfr report number is: 9617016-2021-00003.This final report has been submitted in order to complete the record of the final report (9617016-2021-00000) submission in the emdr system.

• Brand Name: VERSA HD
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 11744994
• MDR Text Key: 250350227
• Report Number: 9617016-2021-00000
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1