BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PATIENT ROTATION BED

    MDR report key: 3083628 · Received April 29, 2013

    Report

    Report Number
    1031452-2013-00814
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A 5310IVC SEMI-ELECTRIC BED WHERE THE FOOT OF THE BED DOES NOT STAY IN THE SPECIFIED POSITION. THIS EVENT COULD POTENTIALLY LEAD TO FOOT OF BED UNEXPECTEDLY DROPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185303 POWERED PATIENT ROTATION BED 890.5225 IKZ INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other