BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED, MANUAL

    MDR report key: 3033925 · Received April 3, 2013

    Report

    Report Number
    1031452-2013-00646
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE BED HAD BROKEN CENTER LINKS WHICH COULD CAUSE THE BED TO BE UNSTABLE AND THE USER COULD POTENTIALLY FALL THROUGH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136903 BED, MANUAL 880.5120 FNJ INVACARE FLORIDA OPERATIONS BED10-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other