BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON AT-HOME

    MDR report key: 1610233 · Received February 5, 2010

    Report

    Report Number
    1045510-2010-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 16, 2009
    Report Date
    February 4, 2010
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM HAS BECOME AWARE OF A HEAD ACTUATOR FAILURE ON THE CLINITRON AT-HOME AIR FLUIDIZED THERAPY BED THAT CAUSED THE HEAD SECTION OF THE BED TO DROP SUDDENLY. THE CAREGIVER WAS RAISING THE PT'S HEAD SECTION OF THE BED AT THE TIME OF FAILURE, BUT THE PT WAS NOT SERIOUSLY INJURED. THE PT INDICATED A HEADACHE AS A RESULT OF THE SUDDEN DROP. A PRELIMINARY INVESTIGATION REVEALED THE THREADS IN THE CLEVIS SLEEVE WERE STRIPPED OUT AND SLIPPED OFF THE END OF THE ACTUATOR'S RETRACTION ROD DURING OPERATION. HILL-ROM WILL SUBMIT A FOLLOW UP REPORT ONCE AN ENGINEERING INVESTIGATION CAN DETERMINE ROOT CAUSE OF THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITRON AT-HOME AIR FLUIDIZED THERAPY BED INX HILL-ROM MANUFACTURING, INC. 90006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1