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

Lot Number 152344

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported allegedly a dose of 14 monitoring units (mu) were delivered for a dibh (deep inhalation breath hold) patient before the patient had reached the gating window.

Manufacturer Narrative

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

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 allegedly a dose of 14 monitoring units (mu) were delivered for a dibh (deep inhalation breath hold) patient before the patient had reached the gating window.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the reported information provided by the customer.The customer initially contacted elekta to investigate a reset motors/wedge fault issue.It was found that the relay module output had been bypassed.The relay module was re-connected and this solved the issue.The machine was then investigated for beam gating and was found to operate as intended within specifications.Due to the issue of the relay module being bypassed according to the customer a patient potentially received 14 mus out of position.Elekta conducted a risk assessment based on information received from the customer that if a patient received a dose of 14 mus out of treatment position (worst case scenario), the impact to the patient would be considered minor as the overall misadministration was (b)(4) of the total treatment.The likelihood of this event occurring again is extremely low (remote) and is within the acceptable region.

• Brand Name: ELEKTA SYNERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgaten 18; sweden, 103 9 3; SW 103 93
• Manufacturer (Section G): ELEKTA LIMITED; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL,
• MDR Report Key: 13257728
• MDR Text Key: 286050984
• Report Number: 3015232217-2022-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 152344
• Date Manufacturer Received: 12/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1