BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4212521 · Received October 30, 2014

    Report

    Report Number
    1031452-2014-16864
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PER END USER'S MOTHER, HER SON WAS IN HIS BED AND THE HEAD SECTION COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697283 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS VC5310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other