BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST

    MDR report key: 800552 · Received December 22, 2006

    Report

    Report Number
    2921578-2006-00005
    Event Type
    Other
    Date Received
    December 22, 2006
    Date of Event
    October 20, 2006
    Report Date
    December 22, 2006
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS REPAIRED. USER ALLOWED MAINTENANCE OF TABLE TO GO BEYOND SAFE USE. REPAIR ORDER CREATED, ITEMS FOR REPAIR IDENTIFIED REPLACEMENT ACTUATOR AND KNOB REPLACEMENT ASSEMBLY. TABLE IS CURRENTLY IN USE.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING HIP ARTHROPLASTY, AND AFTER THE DISTRACTION OF THE RIGHT HIP JOINT WAS APPLIED, AN ATTEMPT WAS MADE TO TILT THE TABLE FOR BETTER ACCESS. THE ANESTHESIOLOGITS WAS UNFAMILIAR WITH THE BED AND DID NOT KNOW IT WOULD NOT ROTATE 180 DEGREES. SHE WAS UNABLE TO GET THE BED TO TILT USING THE HAND CONTROL AND SEEING THE "LOCK/UNLOCK" LEVER ON THE BED, SHE UNLOCKED IT THINKING THAT WAS WHY THE BED WOULD NOT TILT. THE TABLETOP ROTATED AND THE PT WAS LEFT DANGLING BY THE TWO SAFETY STRAPS (ACROSS CHEST AND UNAFFECTED LEG). THE HEALTHCARE TEAM REACTED SWIFTYLY AND WAS ABLE TO MAINTAIN THE SECURITY OF HIS AIRWAY AND REORIENT THE BED. HE WAS MOVED TO ANOTHER BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST OPERATING ROOM TABLE BWN ORTHOPEDIC SYSTEMS, INC. 5803 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other