BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2940336 · Received February 2, 2013

    Report

    Report Number
    1031452-2013-00204
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    February 2, 2013
    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

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE BED22-1633 HOMECARE BED WAS SAGGING IN THE MIDDLE OF ONE SIDE OF THE UNIT, ALTHOUGH THE PATIENT WAS WITHIN THE WEIGHT LIMIT SPECIFICATION FOR THIS BED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45477 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS BED22-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 54 Other