BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 3832309 · Received May 14, 2014

    Report

    Report Number
    1043572-2014-00044
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND IT TO BE OPERATING TO SPECIFICATION; NO ISSUES WERE NOTED AND THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. THE TABLE WAS RETURNED TO SERVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE TABLE IS APPROXIMATELY 18 YEARS OLD AND IS SERVICED AND MAINTAINED BY THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR SURGICAL TABLE DOES NOT STAY IN TRENDELENBURG POSITION. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288127 3080 SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other