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

Device Problem Computer Software Problem (1112)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 during scanning of the scanner band with the scanner assigned to the camera mosaiq opened the wrong patient plan.Based on the available information, there have been no actual mistreatment.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information and elekta inc were unable to reproduce the reported problem.The customer also confirmed that it was an incidental issue and never repeated.The patient was treated with incorrect fields, however this appears to be a one-time occurrence.Elekta physics have performed a severity analysis with the information available and it was determined that if the barcode reader opened the wrong patient serious injury could occur if no other means to identify the correct patient was used.

• 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 ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 7111973
• MDR Text Key: 95470216
• Report Number: 2950347-2017-00031
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 04/24/2018
• 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