BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMSCO QUANTUM 3080 RC/RL SURGICAL TABLE

    MDR report key: 2171908 · Received April 26, 2007

    Report

    Report Number
    1043572-2007-00012
    Event Type
    Other
    Date Received
    April 26, 2007
    Date of Event
    March 8, 2007
    Report Date
    April 24, 2007
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS REMOVED FROM SERVICE FOLLOWING COMPLETION OF THE SURGICAL PROCEDURE. THE HOSPITAL'S IN-HOUSE MAINTENANCE TEAM REPORTEDLY FOUND NO PROBLEMS WITH THE TABLE. A STERIS TECHNICIAN WHO INSPECTED THE TABLE ALSO FOUND NO PROBLEMS WITH IT. THE TECHNICIAN REPORTED, HOWEVER, THAT A DOCTOR AT THE HOSPITAL TOLD HIM THAT A NEW EMPLOYEE HAD BEEN OPERATING THE HAND CONTROL AT THE TIME OF THE INCIDENT AND MAY NOT HAVE HAD THE CONTROL IN THE PROPER MODE (REVERSE ORIENTATION). THE STERIS SERVICE REP RESPONSIBLE FOR THIS ACCOUNT WAS NOTIFIED ABOUT THE INCIDENT AND HAS SINCE CONDUCTED ADD'L IN-SERVICE TRAINING FOR THE HOSPITAL STAFF ON HOW TO PROPERLY OPERATE THE TABLE. NO INJURIES HAVE BEEN REPORTED IN CONNECTION WITH THIS INCIDENT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO QUANTUM 3080 RC/RL SURGICAL TABLE AC POWERED SURGICAL TABLES AND ACCESSORIES FQO STERIS CORPORATION - MONTGOMERY 2151227 NA

    Patients

    Seq Age Sex Outcome Treatment
    1