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

Device Problems Computer Software Problem (1112); Application Network Problem (2879); Patient Data Problem (3197)

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

Event Date 01/02/2015

Event Type  No Answer Provided  

Event Description

It was reported that mu and dose are recorded incorrectly during afs when machine fault occurred.The afs was to have beams treated in the following order: 2, lateral tangent -->4, lateral segment -->3, medial segment --> 1, medial tangent.The alleged error occurred where treatment was interrupted with a wedge field size error between the medial segment and the medial tangent.The result was that mosaiq attributed the cumulative dose from beams 2, 4 and 3 to beam 2.Beams 4 and 3 were allegedly marked on mosaiq as remaining to be delivered, although they were actually delivered.Mosaiq allegedly did not flag the attribution of cumulative dose to beam 2.There was no report of mistreatment based on the available information.

Manufacturer Narrative

Investigation is in progress to determine the cause.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a product configuration and network issue.Mosaiq did not malfunction.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): DAVE KENNEDY - SENIOR QA MANAGER; impac medical systems, inc.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): DAVE KENNEDY - SENIOR QA MANAGER; impac medical systems, inc.; 13723 riverport drive; maryland heights MO 63043
• Manufacturer Contact: christopher pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR ; 4088308023
• MDR Report Key: 4489059
• MDR Text Key: 5497973
• Report Number: 2950347-2015-00005
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: VERSION 2.41.01F8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• 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