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

Device Problem Computer Software Problem (1112)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The investigation concluded that the user was recalculating the dose after approval and did not reapply a dose adjustment after recalculation.Elekta have explained to the site that dose adjustments are not meant to be preserved in this process.Mosaiq is working as designed and intended.

Event Description

The customer reported that each time the bsa is updated on a previously calculated dose, the dose automatically defaults back to the full dose.Based on the available information a patient received one dose of medication that was 25% higher than intended.Dose errors of this magnitude could result in serious injury.

• 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; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 7017198
• MDR Text Key: 91759359
• Report Number: 2950347-2017-00024
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: 00858164002091
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• 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