BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1704 DENTAL CHAIR

    MDR report key: 10349102 · Received July 31, 2020

    Report

    Report Number
    1017522-2020-00011
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 31, 2020
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN AUTHORIZED DEALER SERVICE TECHNICIAN PROVIDED A PHOTO OF THE E1704 DENTAL CHAIR TO KAVO DENTAL TECHNOLOGIES. UPON REVIEW OF THE PROVIDED PHOTO, IT APPEARS THE LOWER TRUSS AREA OF THE DENTAL CHAIR HAS BROKEN. THE EXACT NATURE AND CAUSE OF THE DAMAGE TO THE LOWER TRUSS AREA COULD NOT BE DETERMINED FROM THE PHOTOGRAPH. THERE WAS NO REPORT OF INJURY OR IMPACT TO PATIENT CARE, AND THE AUTHORIZED DEALER SERVICE TECHNICIAN WAS DIRECTED BY THE KAVO DENTAL TECHNOLOGIES, LLC, TECHNICAL SERVICE DEPARTMENT TO ADVISE THE CUSTOMER TO DISCONTINUE USE OF THE DENTAL CHAIR. A FOLLOW UP CALL TO THE DOCTOR'S OFFICE ON 29-JULY-2020 CONFIRMED THROUGH THE OFFICE MANAGER THAT THE CHAIR HAS BEEN REMOVED FROM PATIENT SERVICE. THE DENTAL CHAIR WAS MANUFACTURED IN JUNE 2011 AND IS OVER 8 YEARS OLD AND IS PAST THE EXPECTED LIFE OF THE DEVICE. THIS CONCLUDES THE INVESTIGATION AND THIS REPORT.

    Description of Event or Problem · 1

    AN ALLEGED MALFUNCTION OF MODEL E1704 DENTAL CHAIR SERIAL NUMBER (B)(4) WAS REPORTED TO KAVO DENTAL TECHNOLOGIES, LLC ON (B)(6) 2020 BY AN AUTHORIZED DEALER SERVICE TECHNICIAN. THE REPORT ALLEGED THAT THE MODEL E1704 DENTAL CHAIR TRUSS HAD BUCKLED AND ALLOWING THE CHAIR TO LEAN FORWARD. THERE WAS NO REPORT OF INJURY OR IMPACT TO CUSTOMER CARE AND THE AUTHORIZED DEALER SERVICE TECHNICIAN WAS DIRECTED BY THE KAVO DENTAL TECHNOLOGIES, LLC, TECHNICAL SERVICE DEPARTMENT TO ADVISE THE CUSTOMER TO DISCONTINUE USE OF THE CHAIR. THE DENTAL CHAIR WAS MANUFACTURED IN JUNE 2011 AND IS OVER 8 YEARS OLD AND IS PAST THE EXPECTED LIFE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813893 E1704 DENTAL CHAIR DENTAL CHAIR NRU KAVO DENTAL TECHNOLOGIES, LLC E1704

    Patients

    Seq Age Sex Outcome Treatment
    1