BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCHMARK

    MDR report key: 17760757 · Received September 15, 2023

    Report

    Report Number
    3007278668-2023-00001
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    February 8, 2023
    Report Date
    September 13, 2023
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS, INC.
    Product Code
    INW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DESCRIBED THAT THE PATIENT HAD SAT ON THE LOWER THIRD SECTION OF THE TABLE THAT IIS NOT INTENDED TO BE SAT ON AND THAT THE PATIENT PLACED HERSELF THERE WITHOUT BEING DIRECTED TO DO THAT. IT WAS ALSO REPORTED THAT THE TABLE WAS NOT BROKEN, DID NOT REQUIRE REPAIR AFTER THE INCIDENT, AND THAT THE TABLE CONTINUED TO BE USED AFTER THE INCIDENT. IT WAS NOT DETERMINED HOW THE PATIENT CAME TO FALL OFF THE TABLE. THE DEVICE IS 13 YEARS OLD, THE MODEL HAS NOT BEEN MANUFACTURED IN APPROXIMATELY 10 YEARS, AND THE INVESTIGATION DID NOT FIND ANY INDICATION THAT THE TABLE BROKE, MALFUNCTIONED, OR IN ANY WAY CONTRIBUTED TO THE INCIDENT. THE TABLE CONTINUES TO BE USED IN THE SAME CLINIC TO TODAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT SAT ON THE LOWER THIRD OF A BENCHMARK MODEL E9142. THE PATIENT REPORTEDLY PLACED HERSELF ON THE EDGE OF THE TABLE WITHOUT BEING DIRECTED TO SIT THERE AND WITHOUT ASSISTANCE AND THEN SHE FELL OFF THE TABLE AND WAS INJURED. IT WAS REPORTED THAT IT WAS NOT KNOWN HOW THE PATIENT CAME TO FALL OFF THE END OF THE TABLE BUT THE TABLE WAS NOT BROKEN, DID NOT REQUIRE REPAIR AFTER THE INCIDENT, AND CONTINUED TO BE USED AT THE CLINIC AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294909 BENCHMARK EXAM TABLE INW PIVOTAL HEALTH SOLUTIONS, INC. E9142

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other