FDA Adverse Event Malfunction Summary report: N

IMRIS IMRI 3T V

MDR report key: 24639914 · Received March 19, 2026

Report

Report Number: 3010326005-2026-00002
Event Type: Malfunction
Date Received: March 19, 2026
Date of Event: February 24, 2026
Report Date: March 19, 2026
Manufacturer: IMRIS IMAGING, INC
Product Code: LNH
UDI-DI: 00857534006745
PMA / PMN Number: K212367
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS EVENT WAS REPORTED DUE TO THE LENGTH OF PROCEDURAL DELAY UNDER ANESTHESIA REPORTED BY THE END USER. THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT. THE MANUFACTURER HAS INITIATED INTERNAL CORRECTIVE ACTION TO FURTHER ADDRESS THIS ISSUE.

Description of Event or Problem · 0

THE MAGNET MOVER EXPERIENCED A MECHANICAL MALFUNCTION CAUSING AN UNEXPECTED DOWNTIME CONDITION WITH A PATIENT UNDER ANESTHESIA FOR MORE THAN ONE HOUR, LEADING TO AN EXTENDED PROCEDURAL DELAY. PER THE SITE, THE PATIENT REMAINED STABLE, AND NO ADVERSE EVENTS OR UNANTICIPATED PATIENT OUTCOMES WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE. AFTER THE INITIAL MALFUNCTION WAS CORRECTED, A SEPARATE EVENT RENDERED THE MR SCANNER FULLY INOPERABLE, CAUSING MORE THAN ONE HOUR OF UNPLANNED DOWNTIME WHILE THE PATIENT REMAINED UNDER ANESTHESIA. THE CUSTOMER SERVICE ENGINEER WAS CONTACTED AND RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED NO SERIOUS INJURY OR HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
701174	IMRIS IMRI 3T V	System, nuclear magnetic resonance imaging	LNH	IMRIS IMAGING, INC	120823-000		00857534006745

Patients

Seq	Age	Sex	Outcome	Treatment
1	16 YR	Unknown	Other