BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4113032 · Received September 24, 2014

    Report

    Report Number
    1031452-2014-10743
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 4, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATTRESS FOR THE 5410IVC BED WAS RECEIVED WITH SHARDS OF GLASS IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592979 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other