BEUDAMED
    FDA Adverse Event Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 2021114 · Received March 16, 2011

    Report

    Report Number
    1043572-2011-00017
    Date Received
    March 16, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 16, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE TABLE AND FOUND A SEVERED ELECTRICAL CABLE, MISSING WIRE TIES, AND DAMAGED ELECTRICAL COMPONENTS. THE CABLE BECAME DISLODGED FROM A METAL GUIDE BRACKET AND SUBSEQUENTLY SEVERED BETWEEN THE METAL GUIDE BRACKET AND A HYDRAULIC TILT CYLINDER WHEN THE TABLE WAS COMMANDED TO TILT AT ITS LOWEST HEIGHT. THE SEVERED CABLE CREATED AN ELECTRICAL SHORT CONDITION WHICH DAMAGED ELECTRICAL COMPONENTS AND CAUSED THE REPORTED ODOR AND SMOKE WHEN THE TABLE WAS COMMANDED TO RISE. THE CAUSE OF THE EVENT WAS THE REMOVAL OF THE WIRE TIES WHICH ALLOWED THE CABLE TO BECOME DISLODGED AND TO BECOME SEVERED. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND OTHER SURGICAL TABLES AT THE USER FACILITY THAT HAD MISSING WIRE TIES. THE TECHNICIAN ADVISED THE FACILITY'S BIOMEDICAL DEPARTMENT OF HIS FINDINGS AND THE BIOMEDICAL DEPARTMENT STATED IT WOULD REPLACE THE MISSING WIRE TIES. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. STERIS HAS OFFERED TO REPAIR THE TABLE AND TO PERFORM IN-SERVICE TRAINING ON PROPER PREVENTIVE MAINTENANCE PROCEDURES FOR THIS TABLE AND IS AWAITING A RESPONSE.

    Additional Manufacturer Narrative · 1

    STERIS OFFERED TO REPAIR THE TABLE AND TO PERFORM IN-SERVICE TRAINING ON PROPER PREVENTIVE MAINTENANCE PROCEDURES FOR THIS TABLE, HOWEVER, THE USER FACILITY DECLINED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080 SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other