BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT 1700 DENTAL CHAIR

    MDR report key: 4360995 · Received December 19, 2014

    Report

    Report Number
    1017522-2014-00016
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    Manufacturer
    PELTON & CRANE
    Product Code
    KLC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION IT WAS IDENTIFIED THAT THE TWO WELDED SUPPORT BLOCK ON THE FRONT TRUSS ASSEMBLY HAD FAILED AS A RESULT OF IMPROPER WELDING FROM OUR SUPPLIER AS IT WAS NOT WELDED TO MANUFACTURERS SPECIFICATIONS. PELTON & CRANE HAS ALREADY CONTACTED THE SUPPLIER OF THE FRONT TRUSS ASSEMBLY AND INFORMED THEN OF THIS ISSUE. THE SUPPLIER INFORMED PELTON & CRANE THAT THEY WILL UPDATE FQC DOCUMENT TO INCLUDE A CONFORMITY CHECK OF WELDMENTS TO ENSURE FRONT TRUSS ASSEMBLIES ARE MANUFACTURED TO PELTON & CRANE SPECIFICATIONS.

    Description of Event or Problem · 1

    A DENTAL PROFESSIONAL WAS RECLINING A PATIENT FOR TREATMENT IN A PELTON & CRANE SP17 DENTAL CHAIR WHEN THE LIFT ASSEMBLY BROKE RESULTING IN THE SEAT ASSEMBLY TO FALL BACKWARDS TOWARDS THE FLOOR. THE PATIENT DID NOT FALL OUT OF THE CHAIR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837621 SPIRIT 1700 DENTAL CHAIR DENTAL CHAIR KLC PELTON & CRANE SP17

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR