BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT PLUS

    MDR report key: 820993 · Received February 22, 2007

    Report

    Report Number
    820993
    Event Type
    Malfunction
    Date Received
    February 22, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 22, 2007
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED SHIPMENT OF CARROLL SPIRIT PLUS BEDS FROM MANUFACTURER. ORIGINAL ORDER WAS FOR SIX BEDS - ONE WAS NOT SHIPPED BECAUSE DEFECTS WERE NOTED. OUT OF THE FIVE BEDS WE RECEIVED, THREE DID NOT WORK OUT OF THE BOX. THERE WAS A PROBLEM WITH ELECTRICAL CONNECTIONS ON THE THREE BEDS THAT THE VENDOR'S TECHNICIAN DID COME IN AND REPAIR. (NO SERVICE ORDER LEFT.) ALSO NOTED; THERE DOES NOT APPEAR TO BE ANY SAFETY MECHANISM TO PREVENT THE BED FROM CRUSHING OBJECTS/PEOPLE. A VIDEOTAPE DEMONSTRATING THE BED CRUSHING A WASTEBASKET WAS MADE. EVALUATING CO HAS BEEN CONTACTED AND THEY HAVE REQUESTED A COPY OF THE VIDEOTAPE. THE BEDS WERE RETURNED TO CARROLL AND WE ARE EXPLORING OTHER OPTIONS WITH OTHER MANUFACTURERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRIT PLUS BED, HOSPITAL FNL INVACARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *