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

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

The customer reported that the patient support system height changed after set up.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.After the radiographers set up the patient for the cbct scan they noticed that the couch had moved (before treatment).The patient was removed from the couch and the cbct was re-loaded and repeated to get the correct position.The table movement didn't happen the second time round, and the treatment was continued as normal.It is not known why the patient support system (pss) moved because there were no errors or indication of information being requested or sent for the table to be moved.The table position readouts are only recorded during treatment (not before treatment), hence no record of why the table moved.The couch movement assist shifts were negligible which was not normative suggesting incorrect set up by the customer which led to the difference in heights.The cause cannot be established, however it is possible that operator error came into play, possibly loading a patient without parking/resetting the hexapod between patients caused a registration issue resulting in a table height correction being sent.By reloading the patient within iguide, the height was correctly set, and the patient was rescanned and treated.The prescribed treatment was carried out after the pss height error had been noticed, so no additional mv treatment occurred, and the patient was treated successfully.The prescribed dose is not affected by this issue and would not cause serious mistreatment.

• 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: 13077503
• MDR Text Key: 287023090
• Report Number: 9617016-2021-00005
• 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,Foreign,Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2021
• 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