BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITRON CII AIR FLUIDIZED THERAPY UNIT

    MDR report key: 1195003 · Received October 9, 2008

    Report

    Report Number
    1045510-2008-00018
    Event Type
    Other
    Date Received
    October 9, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 9, 2008
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY THAT WAS USING THIS BED WAS EVACUATED DUE TO HURRICANE IKE THE SAME DAY THAT THIS EVENT OCCURRED (2008). DUE TO THE EVACUATION, THERE HAS BEEN A DELAY IN RETURNING THE BED FOR ENGINEERING EVALUATION. A FOLLOW-UP REPORT WILL BE SENT AS SOON AS THE BED HAS BEEN RETURNED FOR ENGINEERING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THERE WAS SMOKE AND FLAMES COMING FROM THE BED. THE ACCOUNT REMOVED THE PATIENT FROM THE BED AND SPRAYED THE BED DOWN WITH A FIRE EXTINGUISHER. THERE WERE NO INJURIES TO THE PATIENT OR CAREGIVER. THE BED IS NOT AVAILABLE FOR INVESTIGATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE BED HAS BEEN MADE AVAILABLE, AND THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITRON CII AIR FLUIDIZED THERAPY UNIT BED, AIR FLUIDIZED INX HILL-ROM CHARLESTON 0800010009

    Patients

    Seq Age Sex Outcome Treatment
    1