BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRATURE LOWER EXTREMITY COIL

    MDR report key: 6849971 · Received September 7, 2017

    Report

    Report Number
    1056069-2017-00003
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Report Date
    August 14, 2017
    Manufacturer
    CARMA SALUD, S.L.
    Product Code
    LNH
    PMA / PMN Number
    K934396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ARRIVAL TO INVIVO¿S SERVICE AND REPAIR DEPARTMENT THE COIL¿S HOUSING WAS VISUALLY DAMAGED DUE TO EXCESSIVE HEATING AND A SMELL OF BURNT PLASTIC WAS NOTICED, INITIAL INFORMATION CONTAINED WITHIN THE SERVICE RECORD SHOWED THAT THIS MALFUNCTION WAS POTENTIALLY DEVELOPED DURING CLINICAL USE OF THE MRI COIL. HOWEVER AFTER ENGINEERING EVALUATION IT WAS CONCLUDED THAT THIS CONDITION DEVELOPED WHILE THE COIL WAS NOT IN CLINICAL USE AND WAS LEFT UNPLUGGED ON THE MRI TABLE, IN PRINCIPAL THIS MALFUNCTION DOES NOT MEET THE EVENT REPORTING CRITERIA FOR MALFUNCTIONS. IN ADDITION, THE INTERIOR PARTS OF THE COIL WERE VISUALLY INSPECTED BY DEVELOPMENT ENGINEERING AND IT WAS NOTICED THAT THERE WERE CLEAR SIGNS OF OVER-VOLTAGE, OVER-CURRENT THAT RESULTED IN THE ARCING DIELECTRIC BREAKDOWN AND EVENTUALLY LEADING TO THE FAILURE OF THE PRODUCT. CONSISTENT WITH THE PRODUCT DAMAGE FAILURE WHEN THIS TYPE MRI COILS ARE NOR CONNECTED TO THE MRI SYSTEM FOR ANALYSIS. THIS DEVICE SHOULD NOT BE PRESENT IN THE MR SCANNER WHILE DISCONNECTED. WHEN DISCONNECTED, THE HIGH POWER FROM THE BODY COIL WILL CAUSE EXCESSIVE POWER DEVELOP IN THE COIL AND CAUSE THE COIL TO BURN UP. ALL OF THIS INDICATIVE FROM THE FACT THAT THE MATCH COMPONENTS ARE BURNT AND THAT THE POWER RESISTOR CONNECTED AT THE ISOLATION PORT ARE BURNT. A HIGH POWER FROM THE BODY WILL CAUSE THESE HIGH CURRENTS TO DEVELOP WHEN LEFT UNCONNECTED IN THE MAGNET. WITH THE CABLE BEING UNPLUGGED AT THE TIME OF THE EVENT, THE COIL IS NOT IN CLINICAL USE THEREFORE IF THE MALFUNCTION WERE TO RE-OCCUR NO INJURY IS EXPECTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. COIL PART NUMBER IS 9896-031-02462 AND WILL BE UPDATED ON THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE 1.5T HD T/R KNEE/FOOT COIL WAS RETURNED TO INVIVO'S SERVICE AND REPAIR WITH NO INDICATION FROM CUSTOMER OF ESCALATION. WHILE EXAMINING THE PRODUCT IT WAS NOTICED THAT THERE WAS THERMAL DEFORMATION OF THE INNER MOST PORTION (OF THE EXTERIOR HOUSING) WHERE A PATIENTS LEG WOULD BE SCANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629985 QUADRATURE LOWER EXTREMITY COIL QUADRATURE LOWER EXTREMITY COIL LNH CARMA SALUD, S.L. 9896-031-02462 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other