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

Lot Number	600013
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the on-gantry epid (electronic portal imaging device) drifted position over several months due to a loose nut.
Additional 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
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 8540008
• Report Number: 9617016-2019-00003
• Device Sequence Number: 2443624
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Lot Number: 600013
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1