BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SURGICAL TABLE

    MDR report key: 32909 · Received May 10, 1996

    Report

    Report Number
    MW4001186
    Event Type
    Malfunction
    Date Received
    May 10, 1996
    Report Date
    July 17, 1995
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MECHANICAL FAILURE. POSSIBLE INJURY OR DEATH TO PT WHEN EQUIPMENT IN USE. THE UNIT'S MOTOR CONTROL ASSEMBLE FAILED DURING USE, CAUSING THE UNIT TO LOOSE CONTROL OF THE TABLE TOP, WHICH COULD RESULT IN THE PT BEING DROPPED WHEN IN USE. A LOCKPLATE FASTENER THAT SECURES THE TILT CYLINDER TO THE CYLINDER KNUCKLE WAS LOOSE. EXAMINATION OF THE LOCKING MECHANISM REVEALED THE HEX SCREWS COMPLETELY LOOSE ALLOWING THE CYLINDER TO UNSCREW ITSELF FROM THE CYLINDER KNUCKLE. THE MOTOR CONTROL ASSEMBLY CONSISTING OF THE TILT CYLINDER ASSEMBLY IS THE PROBLEM AREA. A LOOSE LOCK PLATE FASTENER THAT SECURES THE TILT CYLINDER TO THE CYLINDER KNUCKLE IS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM SURGICAL TABLE SURGICAL TABLE FQO AMERICAN STERILIZER CO. 30805P

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO