BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS3 BED 9153651161

    MDR report key: 5392488 · Received January 27, 2016

    Report

    Report Number
    1031452-2016-00330
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Report Date
    January 12, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HE HAS A SOLACE MATTRESS AND THE MATTRESS IS FALLING THROUGH THE CENTER CAUSING THE MATTRESS TO BE WORN IN THE CENTER. ALSO STATES THERE ARE SPRINGS MISSING IN VARIOUS SECTIONS OF THE BED SPRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53177 CS3 BED 9153651161 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS G5510

    Patients

    Seq Age Sex Outcome Treatment
    1