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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2020

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 wrong patient chart opens.

Manufacturer Narrative

H6 updated.H10 updated: the investigation was attempted by conducting a thorough evaluation of the product and the reported information.The customer reported that the wrong patient chart opened.A dur (diagnostic utility report) was installed on the customer's device in order to complete a full analysis.The customer has been contacted on numerous occasions for the data required to further investigate the reported problem.All attempts to obtain additional information have been unsuccessful which has prevented a full analysis from the dur.There are many identifying check points, photos and information which is presented to the user between opening a chart and when treatment begins.Patient names and id numbers are displayed at all times and any patient and chart mismatch can be detected by the user and corrected.It is imperative that every healthcare professional ensures that the correct patient id and correct patient chart are confirmed in order to ensure that the correct patient care is provided for the identified patient.This would appear to be a one off occurrence and it has not been reproduced.Based on the information available, there was no actual mistreatment as the customer stopped and restarted the program when they first noticed this issue.

• 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; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 10239114
• MDR Text Key: 197762535
• Report Number: 2950347-2020-00025
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: 00858164002282
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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 Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 01/26/2022
• 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