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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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 an entire field treated when complete partial selected.

Manufacturer Narrative

The investigations were completed by conducting a thorough evaluation of the product and the reported information.The user delivered a partial treatment when a communication error was experienced.When communications were re-established, mosaiq was restarted before the treatment chart was updated to reflect the remaining dose.At this time the user received a dose mismatch warning message which was ignored by the user and they continued delivering the treatment in full instead of delivering the remainder of the treatment.This overdose to the patient is clinically insignificant and is a result of use error.Mosaiq did not have any malfunction and is working as designed and intended.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale, ca
• MDR Report Key: 10081801
• MDR Text Key: 193611188
• Report Number: 2950347-2020-00017
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: 00858164002282
• Combination Product (y/n): N
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1