BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARLO COMFORT EP L PATIENT HOIST

    MDR report key: 5613173 · Received April 27, 2016

    Report

    Report Number
    3007802293-2016-00060
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 27, 2016
    Manufacturer
    BEKA HOSPITEC GMBH
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PRISM IS A DISTRIBUTOR OF (B)(6) PRODUCTS. THE INVESTIGATION BY PRISM SHOW UNINTENDED USE OF THE CARRY BAR CAUSED INCREASED STRESS ON THE BOLT, ALLOWING IT TO FRACTURE AND SEPARATE. THESE MODIFICATIONS WERE NOT AUTHORIZED BY (B)(6) NOR PRISM (B)(4). THE USER SHOULD BE RETRAINED, AS THE USER MANUAL WARNING STATES: "ANY UNAUTHORIZED REPAIRS, MODIFICATIONS AND ADDITIONS ARE NOT PERMITTED FOR SAFETY REASONS AND EXCLUDES MANUFACTURER OF ANY LIABILITY FROM THE RESULTING DAMAGES. MANUFACTURER IS EXCLUDED OF ANY FURTHER LIABILITY FOR DAMAGES RESULTING FROM THE USE OF SPARE PARTS OR ACCESSORIES THAT ARE NOT APPROVED BY THE MANUFACTURER."

    Description of Event or Problem · 1

    INDIVIDUAL WAS BEING TRANSFERRED FROM A WHEELCHAIR BACK TO BED. WHEN MOVING THE WHEELCHAIR OUT OF THE WAY, THE PATIENT FELL; HITTING THE FLOOR WITH THE CARRY BAR FALLING ONTO HIS CHEST. THE INDIVIDUAL WAS TAKEN TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267351 CARLO COMFORT EP L PATIENT HOIST CARLO COMFORT FSA BEKA HOSPITEC GMBH 278800

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization