BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASM, FOOT SECTION W/ MOTOR PACKAGE

    MDR report key: 4823853 · Received June 8, 2015

    Report

    Report Number
    1031452-2015-14209
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 12, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER STATED ONE OF THE BED RAILS IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369464 ASM, FOOT SECTION W/ MOTOR PACKAGE BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS G5510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other