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

Device Problem Computer Software Problem (1112)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/23/2015

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's device analysis results: for this issue to occur: the abnormal termination has to occur during the intersegment after mlc/bm control system loads the next shape and before the linac control system loads its next segment which clears the dose.I.E.The condition which contributes to the hazard is that the incremented control point still has dose associated with it.The dose display will show the actual dose delivered.A finish field is created which uses the incorrect control point for the dose delivered, resulting in a finish field which will underdose.The user delivers the finish field, underdosing the patient without realising that there is anything wrong.Mosaiq records that the total prescribed dose was delivered: the linac dose counter will show the actual dose delivered for the finish field.The following warning is in the integrity 3.1 instructions for use - clinical mode manual, which if followed, would detect this issue: warning 5.2; when an abnormal termination of a field occurs, you must look at the beam mu display and record the value.You must do a check, in the r&v system, that the remaining mu to be delivered in the finish field that results is correct before you continue.If you ignore this warning, it can cause clinical mistreatment.This issue has been fixed in integrity 3.2; during delivery, if the accumulated segment dose for a beam is more than a set value mu greater than the beam dose, the system shall terminate the beam and set the accumulated segment dose to the beam dose.Remedial action/corrective action/preventive action / field safety corrective action this issue has been resolved in integrity 3.2 which has been released as a mandatory modification kit to the field.Time schedule for the implementation of the identified actions: this modification kit has already been released.Further investigations: none.Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause? yes - 2 (b)(6).The following has been updated: email address updated.The following has been updated: establishment name.The following has been updated: manufacturing site/address has been updated.Resubmitting form 3500a due to an administrative error.This has now been corrected so that only "initial" has been checked and not both "initial" and "follow-up" as requested by fda medwatch program department.Correction ticked.The method code and result code that were used in the previous report submitted on 03/31/2015 are obsolete.(b)(4).

Event Description

The customer reported an integrity mu mismatch between mosaiq and the linac dose counter.Two patients were affected by this issue.The first received an underdose of 211 mu for a treatment segment (out of the 2200 mu that was prescribed).The situation on the second patient remains unknown at the time of this report.

• Brand Name: AGILITY
• 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 ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 4646190
• MDR Text Key: 240443030
• Report Number: 9617016-2015-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/31/2015
• 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
• Patient Outcome(s): Other