BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4222558 · Received November 4, 2014

    Report

    Report Number
    3003433498-2014-00235
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) ALLEGED THAT THE MOTOR BURNED OUT AND STARTED SMOKING REALLY BAD AND MELTED THE PLASTIC AROUND THE HEAD MOTOR ON A SOLO BED. PER (B)(6), THE CARE GIVER NOTICED THIS RIGHT AWAY AND CALLED THE FIRE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705214 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE SOLO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other