BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT 3000 DENTAL CHAIR

    MDR report key: 5075914 · Received September 14, 2015

    Report

    Report Number
    1017522-2015-00020
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    PELTON & CRANE
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION BY THE AUTHORIZED (B)(4) DISTRIBUTOR, IT WAS IDENTIFIED THAT THE FOUR MOUNTING BOLTS THAT ATTACHES THE REAR CUSPIDOR BRACKET TO THE DENTAL CHAIR WERE LOOSE WHICH CAUSED THE TOP TWO MOUNTING BOLTS TO BREAK. THE DISTRIBUTOR HAS ALREADY DISPOSED OF THE BOLTS THEREFORE (B)(4) CANNOT COMPLETE THE EVALUATION. THE DENTAL CHAIR IS OVER 10 1/2 YEARS OLD AND IS PAST THE EXPECTED LIFE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DENTAL HYGIENIST WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PATIENT WHEN THE REAR MOUNTED CUSPIDOR FELL OFF THE (B)(4) SP30 DENTAL CHAIR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605632 SPIRIT 3000 DENTAL CHAIR DENTAL CHAIR NRU PELTON & CRANE SP30

    Patients

    Seq Age Sex Outcome Treatment
    1