BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3935832 · Received July 15, 2014

    Report

    Report Number
    3008262382-2014-00291
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    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

    CUSTOMER STATES IT¿S FROM AROUND 2007. SHE STATES THE FOOT FRAME IS ABOUT HALFWAY BROKEN, BUT SHE STATES IT ISN¿T HARMING HER AND SHE¿S BEEN USING IT THIS WAY FOR A WHILE. SHE ALSO STATES THE POWER CORD IS FRAYED AND SHE WRAPPED IT IN ELECTRICAL TAPE. SHE STATES SHE GOT THIS FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413509 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE REHABILITATION EQUIP BAR5301IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other