BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2940058 · Received February 1, 2013

    Report

    Report Number
    1031452-2013-00177
    Date Received
    February 1, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 - IT WAS REPORTED BY THE CONSUMER'S NURSE THE 5410IVC FULL-ELECTRIC BED RAIL WAS BROKEN, RESULTING IN A PATIENT TO FALL ONTO THE FLOOR. MEDICAL INTERVENTION WAS SOUGHT TO TREAT UNSPECIFIED INJURIES. SHOULD WE RECEIVE ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44776 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other