BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS HEADNECK COIL 3.0T

    MDR report key: 8147940 · Received December 10, 2018

    Report

    Report Number
    1056069-2018-00006
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Report Date
    December 3, 2018
    Manufacturer
    CARMA SALUD, S.L.
    Product Code
    MOS
    UDI-DI
    00884838067394
    PMA / PMN Number
    K123492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT WAS SCANNED WHILE THE SENSAVUE MIRROR WAS ATTACHED TO THE NVC COIL. THE MIRROR FOR NVC USED FOR "SENSAVUE" HAS COME OFF AND THE MIRROR HITS THE PATIENT'S EYES. THE SCREWS FOR SECURING THE MIRROR WERE DISENGAGED. FOR THIS REASON, THE MIRROR STRUCK THE PATIENT'S EYES. THE PATIENT'S CORNEA IS HURTING. PATIENT DID NOT RECEIVE SPECIAL TREATMENT FROM HOSPITAL. NCR 37458 WAS CREATED TO QUARANTINE ALL MIRRORS IN STOCK. DURING INSPECTION IT WAS NOTED THAT THE TORQUE OF THE SCREW WAS SET TOO HIGH AND CAUSED THE SCREW TO STRETCH OR THE HEAD WOULD SHEAR OFF. SCAR 19-001 WAS CREATED FOR FURTHER ANALYSIS BY THE VENDER PRECISION INNOVATIONS, INC. DURING THEIR INVESTIGATIONS IT WAS NOTED THAT THE ASSEMBLIES REQUIRED A SECONDARY OPERATION OF UNASSEMBLING AFTER PRECISION INNOVATION SHIPPED. THE MIRROR WAS NOT BEING ASSEMBLED CORRECTLY AND IN ORDER TO UTILIZE THE MIRROR CORRECTLY SITE WOULD HAVE TO DISASSEMBLE THESE TO CORRECT THE MIRROR THEN REASSEMBLE FOR USE. ECR-066751 WAS CREATED TO TO INDICATE ON THE DRAWING THE CORRECT ORIENTATION OF THE MIRROR. ECR-068964 WAS CREATED TO UTILE A MORE APPROPRIATE TORQUE PLUS TO INCLUDE THE USE OF A THREADLOCKER TO ENSURE THE SCREWS DO NOT BACK OUT WHEN IN USE IN THE FIELD. ALL MATERIAL IN HOUSE IS TO BE REWORKED USING THE LATEST APPROVED DRAWING. MOVING FORWARD THE MIRRORS HAVE BEEN CORRECTED ON THE NEXT REVISION DRAWING TO PROVIDE CORRECT POSITIONING OF MIRROR. ADDITIONALLY VENDER TO DEVELOP PERMANENT INSTRUCTION OF SCREW INSTALL INTO FINAL INSPECTION. THE CAUSE OF THE CUSTOMER COMPLAINT AS DESCRIBED ABOVE IS MOST LIKELY ATTRIBUTED TO A DESIGN ERROR. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3 OTHER TEXT : ACCESSORY WAS REPLACED BY FIELD SERVICE ENGINEER

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    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.

    Description of Event or Problem · 1

    WHILE BEING SCANNED, MIRROR ASSEMBLY WAS ATTACHED TO THE MRI COIL. A SCREW HAD PREVIOUSLY FELL OUT OF THE ASSEMBLY AND DURING THE SCAN THE MIRROR DISLODGED FROM THE ASSEMBLY AND FELL TO HIT THE PATIENT'S EYE. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985117 DS HEADNECK COIL 3.0T DS HEADNECK COIL 3.0T MOS CARMA SALUD, S.L. 9896-032-08031 N/A 00884838067394

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other