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

Device Problems Computer Software Problem (1112); Inaccurate Delivery (2339)

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

Event Date 05/05/2015

Event Type  No Answer Provided  

Event Description

It was reported that the beam restarted from the beginning instead continuing and did not finish the fraction correctly; resulting in the delivery of minor extra dose.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the related information.The logs were reviewed and there was no indication that mosaiq malfunctioned.The logs showed that the user kept re-starting mosaiq while the field was being treated and the site did not use complete partial functionality provided in mosaiq to complete the partial treatment.Elekta physics concluded that the severity of the excess dose was negligible.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): IMPAC MEDICAL SYSTEMS, INC.; 100 mathilda place; 5th floor; sunnyvale, CA 94086
• Manufacturer (Section G): IMPAC MEDICAL SYSTEMS, INC.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: pms ; linac house; flemming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 4820308
• MDR Text Key: 5895865
• Report Number: 2950347-2015-00020
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: VERSION 1.60Y1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2010
• 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