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

Device Problem Computer Software Problem (1112)

Patient Problem Radiation Underdose (2166)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reports that a patient has been mistreated due to the wrong image being verified in mosaiq.Based on the available information mistreatment occurred, which could possibly result in serious clinical outcome.

Manufacturer Narrative

Manufacturers narrative - investigation findings: the investigation was completed by conducting a thorough evaluation of the product and the reported information.Engineering analysis indicates user error.The user did not click ok in the image review window so the first shift was not saved into the database.Recommendation is for the user to be sure to click ok in the image review window, this process is documented.The device is working as designed and intended.Specific training materials have been placed in support plus for customers.

• 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; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6002974
• MDR Text Key: 56788648
• Report Number: 2950347-2016-00048
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• 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?: No
• Date Manufacturer Received: 09/09/2016
• 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
• Patient Outcome(s): Other