BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4131179 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06522
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    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

    PER THE STATE OF (B)(6), THE ONE SIDE OF THE RAILS HAD TOO MUCH GIVE IN IT AND THE NURSING HOME WAS CITED FOR A SAFETY ISSUE. THEY HAVE DETERMINED THAT THERE IS A PLASTIC PIECE MISSING FROM ONE OF THE TUBES IN THE BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612950 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN ICCGBEDS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other