BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC1700 DENTAL CHAIR

    MDR report key: 9891719 · Received March 27, 2020

    Report

    Report Number
    1017522-2020-00004
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 27, 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

    DURING THE KAVO DENTAL TECHNOLOGIES, LLC CALL WITH THE DENTIST (DR. (B)(6) OF (B)(6)), DR. (B)(6) INDICATED THE EQUIPMENT DEALER HAD JUST INSTALLED A NEW DENTAL LIGHT ONTO THE DENTAL CHAIR. THE BRAND NAME AND TYPE OF THE DENTAL LIGHT INSTALLED ONTO THE KAVO DENTAL TECHNOLOGIES, LLC DENTAL CHAIR COULD NOT BE PROVIDED. DR. (B)(6) WAS RECLINING THE CHAIR FOR MEDICAL TREATMENT OF A PATIENT. AT THIS TIME, THE DENTAL CHAIR BEGAN WOBBLING IN A SPRING LIKE MOTION 8" BACK AND FORTH. DR. (B)(6) CONFIRMED THE PATIENT DID NOT FALL OUT OF THE CHAIR. HE COMPLETED THE MEDICAL TREATMENT AND THIS OBSERVATION HAD NO IMPACT TO PATIENT CARE. DR. (B)(6) CONFIRMED THERE WERE NO INJURIES DUE TO THIS OCCURRENCE AND NO FURTHER ACTION WAS REQUIRED. DR. (B)(6) INFORMED KAVO DENTAL TECHNOLOGIES, LLC THAT HE KEPT USING THE DENTAL CHAIR FOR A VERY SHORT PERIOD OF TIME, BUT THE DENTAL CHAIR HAS NOW BEEN REMOVED FROM POINT OF USE. THE SERVICE TECHNICIAN PROVIDED PHOTOS OF THE DENTAL CHAIR TO KAVO DENTAL TECHNOLOGIES. UPON OUR REVIEW OF THE PROVIDED PHOTOS, 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 PHOTOGRAPHS. WE REQUESTED THE CHAIR TO BE RETURNED TO KAVO DENTAL TECHNOLOGIES, LLC FOR OUR EVALUATION AND INVESTIGATION. HOWEVER, WE WERE INFORMED THAT THE CHAIR HAS BEEN DISPOSED AND WILL NOT BE RETURNED. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 3-MAR-2020, THE MANUFACTURER RECEIVED A MAILED COPY OF MEDWATCH REPORT NUMBER MW5092884 FROM FDA. THE REPORT WAS GIVEN TO FDA FROM A SERVICE TECHNICIAN WHO REPRESENTS A THIRD-PARTY DENTAL EQUIPMENT DEALER OF EQUIPMENT MANUFACTURED BY KAVO DENTAL TECHNOLOGIES, LLC. THE SERVICE TECHNICIAN WAS DISPATCHED TO DIAGNOSE A DENTAL CHAIR ISSUE. THE REPORT ALLEGED A PATIENT FELL OUT OF THE DENTAL CHAIR. THE SERVICE TECHNICIAN ALLEGED THE MARUS CHAIR MODEL 1702 (MANUFACTURED IN FEBRUARY 2011) SUSTAINED WHAT WAS DESCRIBED AS "A CATASTROPHIC STRUCTURAL FAILURE CAUSING IT TO DROP THE PATIENT". KAVO DENTAL TECHNOLOGIES, LLC CONTACTED THE DENTIST (DR. (B)(6)) DIRECTLY TO OBTAIN ADDITIONAL INFORMATION. THE DENTIST CONFIRMED THE CHAIR BECAME UNSTEADY AND WAS DESCRIBED AS "WOBBLING IN A SPRING LIKE MOTION 8" BACK AND FORTH". DR. (B)(6) CONFIRMED THE PATIENT WAS NOT DROPPED NOR DID THE PATIENT FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353025 DC1700 DENTAL CHAIR DENTAL CHAIR NRU KAVO DENTAL TECHNOLOGIES, LLC DC1702

    Patients

    Seq Age Sex Outcome Treatment
    1