FDA Adverse Event Injury Summary report: N

MOSAIQ

MDR report key: 6173657 · Received December 14, 2016

Report

Report Number: 2950347-2016-00057
Event Type: Injury
Date Received: December 14, 2016
Report Date: December 14, 2016
Manufacturer: IMPAC MEDICAL SYSTEMS, INC.
Product Code: IYE
PMA / PMN Number: K141572
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIST

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. MOSAIQ IS WORKING AS DESIGNED AND INTENDED. THE ISSUE WAS DETERMINED TO BE A USER ERROR. THE MANUFACTURER REVIEWED THE LOG FILES WHICH SHOWED THAT FIELD DELTA WARNINGS WERE PRESENTED TO THE USER PRIOR TO DELIVERY TREATMENT. THESE WARNINGS WERE ACKNOWLEDGED BY THE USER BUT STILL TREATED WITH THE INCORRECT FIELDS.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PATIENT WAS TREATED WITH THE WRONG CONE USING MOSAIQ. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT. DURING ONE FRACTION OF A COURSE OF TREATMENT A PLANNED ELECTRON FIELD WAS DELIVERED WITH AN ELECTRON BLOCK FOR A DIFFERENT PATIENT AND AN ELECTRON APPLICATOR OF THE INCORRECT SIZE FITTED. THIS COULD POTENTIALLY RESULT IN A SERIOUS CLINICAL OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
824753	MOSAIQ	ACCELERATOR, LINEAR, MEDICAL	IYE	IMPAC MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other