BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PATIENT ROTATION BED

    MDR report key: 3243433 · Received July 23, 2013

    Report

    Report Number
    1031452-2013-01437
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED PIN HAS BEEN SHEARED AND BAR IS BENT BY HEADBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343184 POWERED PATIENT ROTATION BED 890.5225 IKZ INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other