MAUDE Adverse Event Report: ELEKTA MOSAIQ

Model Number VERSION 2.41.01JO

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

During treatment of right anterior oblique (rao) boost field, radiation therapist noted that multi-leaf collimator (mlc) appeared retracted.Therapist stopped treatment, notified medical physicist who determined that mlc menu for this field had been changed which caused the mlc's to fully retract in the y-axis.Menu was reset and field was imaged to verify mlc positions.Attending physician notified and reviewed image.He concluded mlc's were now in correct location and ordered delivery of remaining mus.Support services for mosaiq was contacted to confirm when mlc settings were altered.Mosaiq support determined settings were changed after initial verification portal images were acquired.Mosaiq support determined settings were after the initial verification portal images were acquired but before the first fraction of the boost treatment was delivered.Thus, the mlcs were incorrectly retracted on this one beam for about 3.69 fractions.The treatment fields for all the other pts currently under treatment were examined to ensure there was no similar change in mlc settings.The physician, physicist, and dosimetrist recreated the actual treatment in pinnacle (treatment planning system) to determine the effect of mlc retraction on the treatment plan.It was concluded that there was no radiation overdose that would cause impairment to normal tissue function.However, it was noted that the pt's pacemaker (boston scientific) had received 400-450 cgy.A boston scientific representative was called to consult about the dose to the pacemaker.The representative stated that the amount of dose the pacemaker received was significant and the pacemaker needed to be interrogated to determine if damage had occurred.Fortunately, the pt was not pacemaker dependent.The following day ((b)(6) 2015) the boston scientific representative interrogated the pt's pacemaker and concluded that it was working properly.The representative informed the physician.Dates of use: from (b)(6) 2015.Diagnosis or reason for use: squamous cell carcinoma/left lung.Event abated after use stopped or dose reduced: yes.

• Brand Name: MOSAIQ
• Type of Device: MOSAIQ
• Manufacturer (Section D): ELEKTA
• MDR Report Key: 4664194
• MDR Text Key: 5605413
• Report Number: MW5041854
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VERSION 2.41.01JO
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) 2015; ELEKTA INFINITY (LINAC) LINEAR ACCELERATOR -
• Patient Age: 79 YR
• Patient Weight: 109