BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1181957 · Received September 26, 2008

    Report

    Report Number
    1824206-2008-03610
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HI/LOW DRIVE SCREW WAS DIRTY CAUSING THE HI/LOW FUNCTION OF THE BED TO DRIFT. THE TECHNICIAN CLEANED THE DRIVE TO REPAIR THE BED. CHAPTER 6 OF THE SERVICE MANUAL DOCUMENTS A FUNCTION CHECK FOR HI/LOW DRIVE SCREW AS PART OF PREVENTIVE MAINTENANCE. AS PART OF THE PROCEDURE, THIS SHOULD BE INSPECTED FOR PROPER LUBRICATION.

    Description of Event or Problem · 1

    THE HI/LOW FUNCTION OF THE BED DRIFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM RITTER 3600

    Patients

    Seq Age Sex Outcome Treatment
    1