BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFINITY 3

    MDR report key: 788978 · Received June 8, 2006

    Report

    Report Number
    1824206-2006-00027
    Event Type
    Other
    Date Received
    June 8, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 17, 2006
    Manufacturer
    HILL-ROM RITTER
    Product Code
    KNC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD INVESTIGATION REPORTED THE BED WAS INSPECTED AND THE FOOT SECTION LATCHED PROPERLY. PREVENTIVE MAINTENANCE WAS PERFORMED ON THE BED ON 04/25/2006 IN WHICH THE FOOT SECTION WAS CHECKED. THE CONCLUSION IS THAT THE NURSING STAFF MAY NOT BE INSTALLING THE FOOT SECTION PROPERLY. THE HILL-ROM TECHNICIAN IN-SERVICED THE NURSE MANAGER AND DEMONSTRATED THAT IF PROPERLY LATCHED, THE FOOT SECTION CANNOT BE REMOVED, UNLESS THE LATCH IS MANUALLY RELEASED.

    Description of Event or Problem · 1

    DOCTOR ALLEGED THE FOOT SECTION FELL OFF DURING A DELIVERY. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED KNC HILL-ROM RITTER 3700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN