BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCARE

    MDR report key: 2473589 · Received February 21, 2012

    Report

    Report Number
    2135150-2012-00004
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 21, 2012
    Manufacturer
    MEDCARE PRODUCTS
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REP FROM MEDCARE VISITED THIS FACILITY TO INVESTIGATE THE INCIDENT AS WELL AS SERVICE/INSPECT THEIR MACHINES. WHEN THE MEDCARE REP ARRIVED A NEW LOAD CELL HAD BEEN INSTALLED, SO NO NEW EVIDENCE COULD BE GATHERED. BASED ON WHAT THE MAINTENANCE PERSONNEL TOLD US IT WAS DETERMINED THAT THE CAUSE OF THE HANGER BAR COMING FREE FROM THE LOAD CELL WAS THE COTTER PIN THAT WAS INSTALLED, SHEERED OFF. THIS IS THE FIRST WE HAVE HEARD OF AN ISSUE LIKE THIS SO WE AT MEDCARE ARE FURTHER INVESTIGATING THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE RESIDENT WAS BEING TRANSFERRED FROM BED WITH THE ASSISTANCE OF TWO CNA'S AND A MEDCARE (B)(6) LIFT N' WEIGH WHEN THE LOAD CELL AND HANGER BAR CAME FREE AND FELL. THE RESIDENT WAS DROPPED BACK TO THE BED AND THE HANGER BAR FELL ON HER CHEST. THE RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE 600 LB LIFT N' WEIGH FNG MEDCARE PRODUCTS 400013

    Patients

    Seq Age Sex Outcome Treatment
    1