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

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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

The customer reported that they experienced sporadic pss (patient positioning system) height readings change without actual pss movement.Based on the available information there has been no actual mistreatment.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The intermittent nature of this issue meant that the fault was not reproducible.The replacement of various components were completed and it was then determined that the issue was caused by a broken cable intermittently disconnecting.This issue is not a safety issue and can be concluded as inhibited safely as the tolerance set up in the treatment system allows for movement during treatment - in this case up to 2 cm.Upon the third delivery of the dose the system inhibited safely when it thought that this had been exceeded.The customer checked the position of the patient and established that it had not moved, so they then moved the table up and down and re-aligned the patient with the laser.No patients were mistreated.

• Brand Name: ELEKTA SYNERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• MDR Report Key: 7788116
• MDR Text Key: 117718713
• Report Number: 9617016-2018-00005
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K051932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1