FDA Adverse Event Malfunction Summary report: N

MOSAIQ

MDR report key: 7111973 · Received December 13, 2017

Report

Report Number: 2950347-2017-00031
Event Type: Malfunction
Date Received: December 13, 2017
Report Date: April 24, 2018
Manufacturer: ELEKTA INC
Product Code: IYE
PMA / PMN Number: K141572
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: PHYSICIST

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION AND ELEKTA INC WERE UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE CUSTOMER ALSO CONFIRMED THAT IT WAS AN INCIDENTAL ISSUE AND NEVER REPEATED. THE PATIENT WAS TREATED WITH INCORRECT FIELDS, HOWEVER THIS APPEARS TO BE A ONE-TIME OCCURRENCE. ELEKTA PHYSICS HAVE PERFORMED A SEVERITY ANALYSIS WITH THE INFORMATION AVAILABLE AND IT WAS DETERMINED THAT IF THE BARCODE READER OPENED THE WRONG PATIENT SERIOUS INJURY COULD OCCUR IF NO OTHER MEANS TO IDENTIFY THE CORRECT PATIENT WAS USED.

Additional Manufacturer Narrative · 1

THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT DURING SCANNING OF THE SCANNER BAND WITH THE SCANNER ASSIGNED TO THE CAMERA MOSAIQ OPENED THE WRONG PATIENT PLAN. BASED ON THE AVAILABLE INFORMATION, THERE HAVE BEEN NO ACTUAL MISTREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
892850	MOSAIQ	ACCELERATOR, LINEAR, MEDICAL	IYE	ELEKTA INC

Patients

Seq	Age	Sex	Outcome	Treatment
1