BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHOBED

    MDR report key: 2896534 · Received December 26, 2012

    Report

    Report Number
    1932056-2012-00007
    Event Type
    Other
    Date Received
    December 26, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE INADVERTENT UNLOCKING OF THE CASTERS WAS DUE TO THE FACT THAT THE PRODUCT WAS IN USE AT THE CUSTOMER FACILITY FOR THREE YRS LONGER THAN ITS EXPECTED DESIGN LIFE. THE EXTENDED USE OF THE PRODUCT CAUSED EXCESSIVE WARE ON THE MECHANICAL LOCKING MECHANISM ALLOWING IT TO BECOME EASILY UNLOCKED. MEDICAL POSITIONING, INC. HAS DETERMINED IN ITS RISK FILE FOR THIS PRODUCT THAT INADVERTENT BRAKE RELEASE MAY RESULT IN A PT FALL WHICH COULD CAUSE A BRAKE. THE RISK MITIGATION FOR THIS POTENTIALLY HAZARDOUS SITUATION IS TO INCLUDE A CHECK OF THE CASTER LOCKS AS PART OF THE ANNUAL PREVENTIVE MAINTENANCE SCHEDULE NOTED IN THE OWNER'S MANUAL OF MEDICAL POSITIONING, INC. PRODUCTS. HAD THE PREVENTIVE MAINTENANCE SCHEDULE BEEN COMPLETED AT THE USER FACILITY THIS HAZARDOUS SITUATION COULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 1

    THE CUSTOMER OWNS AN ECHOBED MODEL 1222 WHICH WAS TEN (10) YRS OLD, WHICH IS THREE (3) RS OUTSIDE OF IT'S SEVEN (7) YR DESIGN LIFE. THE PRODUCT UTILIZES A CENTRAL BRAKING (SINGLE PEDAL) SYSTEM TO LOCK THE PRODUCTS CASTERS (WHEELS). AS THE PT WAS LEANING AGAINST THE SIDE OF THE TABLE TO GET ON IT FOR THE PROCEDURE, THE BRAKES CAME UNLOCKED AND THE BED ROLLED AWAY FROM THE PT. THE PT TEMPORARILY LOST HIS BALANCE AND HIS BACK MADE CONTACT WITH THE SAFETY RAIL BRACKET CAUSING A SMALL CONTUSION. IN THIS CASE, THE PT WAS ABLE TO REGAIN HIS BALANCE BEFORE FALLING ALL THE WAY TO THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOBED ECHOBED LGX MEDICAL POSITIONING, INC. 1222

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other