BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS3 BED 9153651161

    MDR report key: 5210913 · Received November 9, 2015

    Report

    Report Number
    1031452-2015-16677
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Report Date
    October 19, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEIR CUSTOMER STATES THAT THE SIDE RAILS HAVE BROKEN AND FALLEN OFF OF THE BED. CUSTOMER DID NOT HAVE ANY MODEL OF THE SIDE RAILS. SIDE RAILS WERE NOT ORDERED AT THE TIME THE BED WAS ORDERED PER THE INVOICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742542 CS3 BED 9153651161 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1