BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080-R SURGICAL TABLE

    MDR report key: 6786289 · Received August 10, 2017

    Report

    Report Number
    1043572-2017-00054
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 10, 2017
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROCEDURE DELAYS OR CANCELLATIONS WERE REPORTED. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL TABLE AND FOUND THE SINGLE FLOOR LOCK CYLINDER REQUIRED REPAIR. AS THE FLOOR LOCK CYLINDER WAS NOT OPERATING PROPERLY, HYDRAULIC FLUID LEAKED FROM THE CYLINDER LOCATED AT THE HEAD-END OF THE TABLE. THE TECHNICIAN REPLACED THE FLOOR LOCK CYLINDER, TESTED THE UNIT AND CONFIRMED THE TABLE TO BE OPERATING PROPERLY. THE TABLE WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED HYDRAULIC FLUID LEAKING FROM THEIR SURGICAL TABLE. DUE TO THE HYDRAULIC FLUID LEAK, AN EMPLOYEE NEAR THE SURGICAL TABLE REPORTEDLY SLIPPED AND FELL. THE EMPLOYEE DID NOT SUSTAIN AN INJURY AND NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567510 3080-R SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1