BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3003030 · Received March 13, 2013

    Report

    Report Number
    1031452-2013-00545
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THE BED HEAD AND BED END WILL NOT MOVE UP AND DOWN. PATIENTS BACK IS HURTING DUE TO BED NOT MOVING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105605 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS GBED-51IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 Other