FDA Adverse Event Malfunction Summary report: N

MOSAIQ

MDR report key: 7047866 · Received November 21, 2017

Report

Report Number: 2950347-2017-00016
Event Type: Malfunction
Date Received: November 21, 2017
Report Date: November 21, 2017
Manufacturer: ELEKTA INC.
Product Code: IYE
PMA / PMN Number: K141572
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE DEVICE LOST CONNECTION WHILST THE DATA WAS BEING TRANSFERRED TO THE RECORD. WITH THE DATA FROM THE MACHINE LOG THE USER (WITH ASSISTANCE FROM ELEKTA PRODUCT SUPPORT) ARE ABLE TO VERIFY THE ACTUAL TREATMENT AND THE USER COULD MANUALLY RECORD THE TREATMENT OR CORRECT ANY INCOMPLETE/ INCORRECT TREATMENT. THIS ISSUE WOULD NOT LEAD TO SERIOUS INJURY AND CAN BE IDENTIFIED EASILY. THERE WAS NO MISTREATMENT IN THIS CASE. MFR REPORT NUMBER CORRECTION: PLEASE NOTE THAT THIS INFORMATION HAS PREVIOUSLY BEEN SUBMITTED AS AN INITIAL AND FOLLOW-UP REPORTS UNDER AN INCORRECT MFR REPORT NUMBER. THESE WERE SUBMITTED AS FOLLOWS: 0290347-2017-00016 INITIAL REPORT, SUBMITTED 02-AUGUST-2017, SUBMITTED ELECTRONICALLY. 0290347-2017-00016 FOLLOW-UP REPORT #1, SUBMITTED 31-OCT-2017, SUBMITTED ELECTRONICALLY. AS A RESULT OF SUBMITTING THESE TWO REPORTS WITH AN INCORRECT MFR REPORT NUMBER, THE TWO HAVE BEEN MERGED AND RESUBMITTED IN THIS REPORT UNDER THE CORRECT MFR REPORT NUMBER.

Description of Event or Problem · 1

THE CUSTOMER HAS REPORTED THAT ON OCCASION, SOME RECORDING PROBLEMS WITH THE MOSAIQ SEQUENCER (ON THE SYNERGY LINAC) HAVE RESULTED IN THE TREATMENT NOT BEING RECORDED. IN THESE CASES, MANUAL REGISTRATION OF THE TREATMENT HAS TO BE CARRIED OUT BY THE USER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
830698	MOSAIQ	ACCELERATOR, LINEAR, MEDICAL	IYE	ELEKTA INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1