BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER RELAX+ TABLE

    MDR report key: 4744925 · Received April 30, 2015

    Report

    Report Number
    1037955-2015-00010
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    March 31, 2015
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EXAMINATION OF THE DEVICE, IT WAS FOUND THAT 6 OUT OF THE 8 BOLTS THAT SECURE THE SUPPORT BAR INTO THE BEARING PACKS WERE MISSING. BASED ON THE APPEARANCE OF THE REMAINING BOLTS AND THE EIGHT THREADED SOCKETS HAVING NO SIGNS OF SHEAR, IT IS LIKELY THAT THESE BOLTS HAD EITHER BACKED THEMSELVES OUT OF THEIR THREADED SOCKETS OR HAD BEEN REMOVED AT SOME POINT AFTER THE TABLE WAS IN USE. IT WAS DETERMINED THAT ALL OF THESE BOLTS THAT SECURE THE SUPPORT BAR INTO THE BEARING PACKS WERE PRESENT AND PROPERLY TIGHTENED TO DORNIER SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE CAUSE OF THIS FAILURE IS INDETERMINATE. DORNIER (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER (B)(4) (THE MANUFACTURER) PER EXEMPTION NUMBER (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR WAS GETTING READY TO TREAT HIS LAST PATIENT OF THE DAY. WHEN HIS PATIENT SAT ON THE CENTER SECTION OF THE TABLE, THE TABLE COLLAPSED AND THE PATIENT FELL TO THE FLOOR. PATIENT WAS ABOUT (B)(6). THE PATIENT WAS NOT INJURED. NONE OF THE TABLE TOP PIECES WERE DAMAGED OR FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284180 DORNIER RELAX+ TABLE RELAX+ TABLE LNS DORNIER MEDTECH SYSTEMS GMBH K1018869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other