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

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

The customer reported that the table brake was not working.

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.The customer reported that the table brake was not working.It was ascertained that a chip on the level translator unit (ltu) printed circuit board (pcb) failed in a specific way that allows the patient treatment table (ptt) brakes to be disengaged when the brake status light buttons are illuminated.If a fault should occur, the system is free of unacceptable risk during the expected service life under single fault conditions.The customer's ltu pcb has been replaced and the system is now working as expected.

• Brand Name: ELEKTA SYNERGY PLATFORM
• 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: 14219524
• MDR Text Key: 299293377
• Report Number: 9617016-2022-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K192242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• 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: 03/28/2022
• 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