MAUDE Adverse Event Report: DAVID KENNEDY - SENIOR QA MANAGER MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problems Computer Software Problem (1112); Off-Label Use (1494)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

Field 8b (non-bolus) was intended to be selected, 6b (bolus) was sent to the machine and recorded.Investigation continuing.

Manufacturer Narrative

Additional information: the investigation was completed by conducting a thorough evaluation of the product and the reported information.It has been concluded that the issue was use error, and the product worked as designed and expected.The site indicated that they manually selected the field to treat instead of using treatment calendar.The treatment plan was designed to have fields treated with and without bolus on alternating days of treatment.During two fractions of this course of treatment the user incorrectly manually selected the bolus treatment field when the un-bolused field was intended.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): DAVID KENNEDY - SENIOR QA MANAGER; 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; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5843080
• MDR Text Key: 51124695
• Report Number: 2950347-2016-00036
• 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: health professional,other,use
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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
• Date Manufacturer Received: 07/05/2016
• 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