FDA Adverse Event Other Summary report: N

MAGNITUDE MRI PATIENT MONITOR

MDR report key: 551836 · Received September 15, 2004

Report

Report Number
551836
Event Type
Other
Date Received
September 15, 2004
Date of Event
July 28, 2004
Report Date
August 27, 2004
Manufacturer
INVIVO RESEARCH, INC.
Product Code
DRT
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

THE MRI SETUP FOR ALL OF THE SCANNERS REQUIRES ANESTHESIA MACHINES BE EASILY ACCESSIBLE IN THE EVENT OF AN EMERGENCY. IN THIS CASE, THE INVIVO MRI COMPATIBLE MONITOR WAS USED, AND CONSEQUENTLY THE ACCOMPANYING AC ADAPTER WITH THE ANESTHESIA MACHINE.ON THIS DAY, THE ANESTHESIA TEAM WAS JUST COMPLETING A MRI CASE AND THE TECH WAS WHEELING OUT THE MACHINE/MONITOR SET-UP EXPLAINED ABOVE. DURING THIS TIME THE SET-UP CAME CLOSE TO THE SCANNER AND THE INVIVO AC ADAPTER FLEW OFF THE TOP OF THE MACHINE AND TOWARDS THE PATIENT WHO WAS STILL IN THE SCANNER. TECH CAUGHT THE OBJECT. UNFORTUNATELY, HEALTHCARE WORKER'S HAND WAS NOW PINNED BETWEEN THE AC ADAPTER AND THE SCANNER. OTHER PEOPLE PRESENT ASSISTED IN REMOVING THE TRAPPED HAND. LUCKILY, THE PATIENT WAS NOT HARMED, AND THE TECH WAS QUICKLY TAKEN TO ER. HEALTHCARE WORKER SUFFERED NO FRACTURES, BUT WAS REQUIRED TO WEAR A SPLIT.IT IS IMPORTANT TO NOTE THAT THE MONITOR CANNOT BE PLUGGED DIRECTLY INTO A WALL SOCKET. IT DOES REQUIRE THE AC ADAPTER. THERE IS AN OPTION OF USING BATTERY POWER TO RUN THE MONITOR, BUT DUE TO THE LENGTH OF FACILITY'S CASES FACILITY ALWAYS KEEPS THE MONITOR PLUGGED. THE INVIVO AC ADAPTER DOES HAS A SMALL 1" X 1/2" STICKER, WHICH ALERTS THE USER TO KEEP THE DEVICE "10 FT. (3 METERS) AWAY FROM THE MAGNET." THIS CONSTRAINT WAS NEVER MADE AWARE TO FACILITY BY THE INVIVO REPS DURING INSTALLATION. IN ADDITION, THE VELCRO STRAPS ON THE BOTTOM OF THE ADAPTER WERE NEVER ATTACHED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAGNITUDE MRI PATIENT MONITOR MONITOR DRT INVIVO RESEARCH, INC. * 42260
2 * AC ADAPTER DRT * 3450 SERIES *

Patients

Seq Age Sex Outcome Treatment
1 *