BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 764196 · Received October 31, 2005

    Report

    Report Number
    1051786-2005-00009
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    August 19, 2005
    Report Date
    August 25, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY PURCHASED A NEW POWER ADAPTER AND THE PT MONITOR IS BACK IN SERVICE. THE PT MONITOR'S POWER ADAPTER CONTAINS A YELLOW LABEL WHICH INDICATES THE FOLLOWING: "ATTENTION KEEP 10 FT. (3 METERS) AWAY FROM MAGNET. MOUNT TO HORIZONTAL SURFACE USING VELCRO STRIPS. ADAPTER IS MAGNETIC, INDOOR USE ONLY." IN ADDITION TO THE ABOVE-DESCRIBED LABEL ON THE POWER ADAPTER, THE OPERATIONS MANUAL FOR THE PT MONITOR CONTAINS A CAUTIONARY STATEMENT INDICATING THAT THE PT MONITOR'S POWER ADAPTER MUST BE KEPT AT LEAST 10 FEET AWAY FROM THE MAGNET. THE FACILITY CONFIRMED THAT THE ABOVE-REFERENCED LABEL WAS INTACT ON THE PT MONITOR'S POWER ADAPTER. ALSO, THE FACILITY STATED THAT, AT THE TIME OF THE EVENT, THE PT MONITOR'S POWER ADAPTER WAS LESS THAN FIVE (5) FEET AWAY FROM THE MAGNET. IN 2004, AS A RESULT OF AN INCIDENT WHERE THIS PT MONITOR'S POWER ADAPTER WAS PULLED INTO THE MAGNET, THE ABOVE-DESCRIBED LABEL ON THE PT MONITOR'S POWER ADAPTER WAS ENHANCED. THE MAGNETIC PROPERTIES OF THE PT MONITOR'S POWER ADAPTER AND THE EXISTENCE OF THE POSSIBILITY THAT THE PT MONITOR'S POWER ADAPTER CAN BE PULLED INTO THE MRI MAGNET WERE REINFORCED. ADDITIONALLY, THE SIZE OF THE LABEL WAS INCREASED AND 3 LABELS ARE AFFIXED TO THE PT MONITOR'S POWER ADAPTER, INSTEAD OF 1. THIS ENHANCEMENT WAS MADE MANDATORY IN ALL SHIPMENTS OF NEW POWER ADAPTERS FOLLOWING THE EFFECTIVE DATE OF THE ENHANCEMENT. AS A RESULT OF THE EVENT DESCRIBED HEREIN, THE MFR PERFORMED AN ASSESSMENT AS TO THE NECESSITY OF MAKING THE LABELING ENHANCEMENT MANDATORY TO ALL POWER ADAPTERS FOR THIS PT MONITOR IN THE FIELD. AS A RESULT OF THE ABOVE-REFERENCED ASSESSMENT, THE MFR WILL BE CONDUCTING A FIELD NOTIFICATION IN ORDER TO REINFORCE THE MAGNETIC PROPERTIES OF THE PT MONITOR'S POWER ADAPTER WITH USERS AND TO FURTHER STATE THE EXISTENCE OF THE POSSIBILITY THAT THE PT MONITOR'S POWER ADAPTER CAN BE PULLED INTO THE MRI MAGNET. THE MFR WILL ALSO MAKE ADD'L LABELS AVAILABLE FOR USERS, AT NO CHARGE.

    Description of Event or Problem · 1

    THE FACILITY STATED THAT THEY WERE SETTING UP THE ROOM FOR AN MRI TO BE PERFORMED. TECHNICIANS WERE MOVING THE PT MONITOR AND THE PT MONITOR'S POWER ADAPTER AND THE PT MONITOR'S POWER ADAPTER WERE PULLED INTO THE MRI BORE. AS A RESULT, THE PT MONITOR'S POWER ADAPTER WAS DAMAGED. THE FACILITY REPORTED THAT THERE WAS NO PT IN THE MRI ROOM AT THE TIME OF THE EVENT AND NO TECHS/USERS WERE INJURED AS A RESULT OF THE EVENT. THE FACILITY STATED THAT THE PT MONITOR'S POWER ADAPTER WAS LESS THAN FIVE (5) AWAY FROM THE MAGNET AT THE TIME OF THE EVENT. THE FACILITY INDICATED THAT THE TECH MOVING THE DEVICE IS FAMILIAR WITH THE POWER ADAPTER'S MAGNETIC PROPERTIES. THE FACILITY REPORTED THAT THE MRI ROOM IS SMALL AND THERE IS NOT MUCH SPACE TO PUT EQUIPMENT SO THEY DO WHAT THEY CAN WHEN THEY NEED TO MOVE EQUIPMENT. THE FACILITY PURCHASED A NEW POWER ADAPTER FOR THEIR PT MONITOR AND THE PT MONITOR IS BACK IN SERVICE AND FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE POWER ADAPTER DRT INVIVO CORPORATION AS153 358020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other