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

Lot Number 600013

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

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 the on-gantry epid (electronic portal imaging device) drifted position over several months due to a loose nut.

Manufacturer Narrative

H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The on-gantry epid (mv panel) has drifted out of position over several months.It was found that the nuts that lock the panel position have come loose and allowed the panel to move out of position.There is a 6-monthly preventative maintenance check for these nuts, but this incidence has occurred before this check is due.There is no specified torque setting for tightening the nuts.An assessment was made for the potential for clinical mistreatment, patient injury, clinical user injury and service user injury.The highest level of risk is serious, low.The classification of the risk is acceptable.

• Brand Name: ELEKTA UNITY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 8540008
• MDR Text Key: 142769298
• Report Number: 9617016-2019-00003
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (y/n): N
• PMA/PMN Number: K182076
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 600013
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1