MAUDE Adverse Event Report: ELEKTA INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  Injury  

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 a wrong shift from xvi.

Manufacturer Narrative

Updated with udi number.The issue cannot be reproduced internally and the customer was unable to provide the steps they used to reproduce the problem.It is concluded that mosaiq is working as designed and intended and this is user error.Based on the available information, a patient was mistreated in this case.The mistreatment could possibly lead to serious injury.This follow-up #1 report was submitted on 26 january 2018, under the wrong mfr report number due to an administrative error.It was reported under mfr no.2950347-2018-00030, but should have been reported under mfr no.2950347-2017-00030.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA INC.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: pms ; linac house; flemming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 7094730
• MDR Text Key: 94059791
• Report Number: 2950347-2017-00030
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2017
• 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
• Patient Outcome(s): Other