BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT 1700 CHAIR

    MDR report key: 6358149 · Received February 24, 2017

    Report

    Report Number
    1017522-2017-00008
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 2, 2017
    Manufacturer
    PELTON & CRANE
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE CHAIR WAS RETURNED TO PELTON AND CRANE. OUR INITIAL EVALUATION INDICATED THE TRUSS ASSEMBLY HAD FAILED WHICH WOULD BE CONSISTENT WITH THE REPORTED COMPLAINT. HOWEVER, UPON FURTHER EVALUATION, IT WAS IDENTIFIED THAT SOMEONE HAD MODIFIED THE TRUSS ASSEMBLY BY DRILLING AND TAPPING 4 LARGE HOLES INTO THE TRUSS ASSEMBLY AND HAD SOME TYPE OF UNAUTHORIZED METAL BRACKET ATTACHED TO THE CHAIR UTILIZING THESE 4 HOLES WHICH WAS LOCATED IN THE SAME AREA AS THE TRUSS ASSEMBLY FAILURE. (B)(6) CONTACTED THE DISTRIBUTOR WITH THIS INFORMATION WHO THEN CONTACTED THE DOCTORS OFFICE. DURING BACK AND FORTH COMMUNICATION, PELTON AND CRANE WAS GIVEN CONFLICTING AND INCONSISTENT INFORMATION AS TO THE PURPOSE OF THESE UNAUTHORIZED 4 DRILLED AND TAPPED LARGE HOLES AND ATTACHED BRACKET. THE DISTRIBUTOR INFORMED PELTON AND CRANE THAT THEY WERE NOT INVOLVED WITH THIS MODIFICATION AND WAS UNAWARE IT TOOK PLACE AS THIS WAS SOLELY DONE BY THE DENTAL OFFICE FACILITY SERVICE DEPARTMENT. AS A RESULT OF THIS UNKNOWN AND UNAUTHORIZED MODIFICATION, THE ROOT CAUSE OF FAILURE IS IMPROPER SERVICE BY THE END USER.

    Additional Manufacturer Narrative · 1

    THE DENTAL CHAIR IS IN THE PROCESS OF BEING RETURNED TO PELTON & CRANE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PELTON & CRANE DISTRIBUTOR THAT A DENTAL HYGIENIST WAS RECLINING A PATIENT IN A PELTON & CRANE SP17 DENTAL CHAIR WHEN THE CHAIR BECAME NONRESPONSIVE AND THEN RECLINED BACK FURTHER. THE DENTAL HYGIENIST THEN HELPED THE PATIENT OUT OF THE CHAIR AND ASKED IF THE PATIENT WAS OKAY AND THE PATIENT SAID HE WAS. THE DENTAL HYGIENIST THEN TRIED AGAIN TO RECLINE THE PATIENT IN THE DENTAL CHAIR AND AS THE CHAIR WENT BACK IT TIPPED ALL THE WAY BACK AND APPEARED TO HAVE BROKEN THE LINKAGE. THE HYGIENIST AGAIN HELPED THE PATIENT OUT OF CHAIR AND THE PATIENT WAS OK. THERE WERE NO INJURIES REPORTED. THE PATIENT WAS MOVED TO ANOTHER OPERATORY TO PERFORM THE DENTAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141673 SPIRIT 1700 CHAIR DENTAL CHAIR NRU PELTON & CRANE SP17

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR