BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATIONI

    MDR report key: 1480250 · Received September 17, 2009

    Report

    Report Number
    1051786-2009-00010
    Event Type
    Injury
    Date Received
    September 17, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 20, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K040915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED TO THE DEVICE MANUFACTURER THAT HE EVALUATED THE DEVICE, AND COULD NOT FIND ANY PROBLEMS, BUT WAS REQUESTING THE DEVICE MANUFACTURER'S ASSISTANCE IN EVALUATING THE DEVICE FURTHER. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE TRAVELED TO THE USER FACILITY, AND EVALUATED THE DEVICE INVOLVED IN THE REPORTED EVENT. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE COULD NOT FIND ANY PROBLEMS WITH THE DEVICE WHILE ON SITE. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE PERFORMED OPERATIONAL AND FUNCTIONAL TESTING ON THE DEVICE ACCORDING TO INTERNAL PROCEDURES, USING THE SAME ACCESSORIES THAT WERE IN USE DURING THE REPORTED EVENT. ALL TESTING CONDUCTED BY THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE PASSED, AND NO MALFUNCTION OF THE MONITORING SYSTEM WAS DETECTED. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE CONSULTED WITH THE USER FACILITY'S BIOMEDICAL ENGINEER REGARDING MAINTENANCE INSPECTIONS THAT, PER THE INSTRUCTION FOR USE, SHOULD BE DONE ROUTINELY ON THE DEVICE AS WELL AS ON AN ANNUAL AND SEMI-ANNUAL BASIS. ALSO, IN-SERVICE TRAINING COVERING BASIC OPERATION OF THE DEVICE (PER THE INSTRUCTIONS FOR USE) WAS REQUESTED BY THE USER FACILITY AND THIS TRAINING WAS CONDUCTED DURING THIS SITE VISIT, AS WELL IN DEPTH APPLICATION TRAINING WAS ALSO REQUESTED BY THE USER FACILITY. THIS TRAINING IS CURRENTLY SCHEDULED TO OCCUR IN EARLY OCTOBER. THE USER FACILITY REPORTED TO THE DEVICE MANUFACTURER THAT THE DEVICE IS BACK IN SERVICE AND WILL CONTINUE TO BE UTILIZED AS A SECONDARY/BACK-UP MONITORING DEVICE. THE DEVICE MANUFACTURER CANNOT RULE OUT THE USE OF THE DEVICE AS A CONTRIBUTING FACTOR IN THE EVENT. WHILE THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE WAS CONDUCTING HIS SITE VISIT, THE USER STATED THAT THEY WERE NOT FAMILIAR WITH THIS MONITORING EQUIPMENT, AND THAT THERE WAS A LOT OF CONFUSION IN THE MRI SUITE AT THE TIME OF THE EVENT. THE USERS STATED THAT THEY WERE FUMBLING WITH THE MONITORING DEVICE WHILE TRYING TO ESTABLISH MONITORING FOR THE PT. WHILE THE USER WAS TROUBLESHOOTING THE MONITORING DEVICES, THE PT CODED BUT WAS SUCCESSFULLY REVIVED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT, AFTER EXPERIENCING PROBLEMS WITH THEIR PRIMARY MONITORING DEVICE (SEE REPORT 1051786-2009-00009), THE USER SWITCHED TO THEIR SECONDARY MONITORING DEVICE. THE USER REPORTED THAT THEY EXPERIENCED DIFFICULTY OBTAINING A GOOD ECG WAVEFORM WITH THE SECONDARY MONITORING DEVICE AND THIS WAS THE SAME PROBLEM THEY EXPERIENCED WITH THE PRIMARY MONITORING DEVICE. WHILE THE USER WAS TROUBLESHOOTING THE MONITORING DEVICES, IT WAS REPORTED THAT THE PT CODED. THE PT WAS SUCCESSFULLY REVIVED. THE USER CLAIMED THAT THE PT WAS CONNECTED TO BOTH THE PRIMARY AND SECONDARY MONITORING DEVICES AT THE SAME TIME WHEN EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATIONI 3150 MAGNITUDE MRI PATIENT MONITOR MHX INVIVO CORPORATION 3150M

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention