BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HC150 FLEXIBLE INTRAOPERATIVE HEAD COIL

    MDR report key: 14465859 · Received May 21, 2022

    Report

    Report Number
    3010326005-2022-00007
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 20, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    MOS
    UDI-DI
    00857534006240
    PMA / PMN Number
    K103506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FLEX COIL WAS RETURNED FOR ANALYSIS AND SHOWED SIGNS OF EXCESSIVE WEAR. A SHOCK INDICATOR WAS TRIPPED INDICATING PRIOR MECHANICAL SHOCK. THE CONNECTION POINT OF THE CABLE ASSEMBLY TO THE COIL ASSEMBLY SHOWED SIGNS OF FRACTURE OR DISENGAGEMENT AS WELL AS ATTEMPTED USER REPAIR WITH GAUZE OR TAPE. BASED ON AGE, THE COIL IS PAST ITS USEFUL SERVICE LIFE. BASED ON COMMUNICATIONS WITH THE REPORTER, THE COIL PASSED A SITE QUALITY ASSURANCE CHECK TWO DAYS PRIOR TO THE CASE, AND IT IS POSSIBLE THE COIL COULD PERFORM INTERMITTENTLY IN ITS CONDITION. THE PROBABLE ROOT CAUSE OF THE REPORTED FUNCTIONAL ISSUE IS AGE PAST SERVICE LIFE AND CONDITION AS A RESULT OF HANDLING.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED THAT AN IMRIS LOWER FLEX COIL FAILED TO FUNCTION WHEN USED FOR INTRA-OPERATIVE MR IMAGING. THE NEUROSURGEON HAD REQUESTED AN INTRA-OPERATIVE BRAIN SCAN AFTER TUMOR REMOVAL AND A SYSTEM ERROR MESSAGE WAS PRODUCED WHEN THE LOWER FLEX COIL WAS PLUGGED IN. THE MR MAGNET WAS RETURNED TO HOME POSITION, POWER CYCLED, AND THEN RETURNED TO THE OPERATING ROOM; HOWEVER, THIS DID NOT RESOLVE THE ERROR. THE COIL WAS UNSUCCESSFULLY PLUGGED INTO A DIFFERENT PORT AS WELL. THE UPPER FLEX COIL WAS THEN MOVED TO THE LOWER POSITION, AND A WIRELESS INSITU COIL WAS USED IN THE UPPER POSITION, AND IMAGING WAS THEN SUCCESSFULLY OBTAINED. THE PATIENT WAS UNDER EXTENDED ANESTHESIA FOR APPROXIMATELY TWO HOURS AT THE SURGEON'S DISCRETION DURING TROUBLESHOOTING BEFORE THE IMAGING WAS PRODUCED. THE IMAGING RESULTS CONFIRMED THERE WAS NO REMAINING TUMOR TO RESECT, AND NO PATIENT HARM WAS REPORTED AS A RESULT OF THE DELAY OR EXTENDED TIME UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521696 HC150 FLEXIBLE INTRAOPERATIVE HEAD COIL COIL, MAGNETIC RESONANCE, SPECIALTY MOS IMRIS - DEERFIELD IMAGING, INC. HC150 00857534006240

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female