BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXICAIR ECLIPSE LOW AIRLOSS THERAPY UNIT

    MDR report key: 1790607 · Received August 3, 2010

    Report

    Report Number
    1045510-2010-00008
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 3, 2010
    Manufacturer
    HILL-ROM
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM WAS NOTIFIED OF A PLASTIC BAG OF MISCELLANEOUS HARDWARE FOUND WITHIN THE MATTRESS OF A FLEXICAIR ECLIPSE LOW AIRLOSS THERAPY UNIT. A FAMILY MEMBER UNZIPPED THE COVERLET AND DISCOVERED THE BAG BETWEEN THE AIR CUSHIONS AND COVERLET AFTER THE PT HAD COMPLAINED ABOUT DISCOMFORT UNDER HIS BACKSIDE. HILL-ROM'S SERVICE TECH EXAMINED THE BAG CONTENTS AND VERIFIED IT WAS NOT CONSISTENT WITH HARDWARE USED IN SERVICING HILL-ROM DEVICES. THE TECH WAS UNSURE HOW THE BAG GOT INTO THE MATTRESS BUT DETERMINED THE ORIGINALLY PLACED DEVICE WAS SWAPPED BY HOSPITAL STAFF WITH AN IDENTICAL DEVICE THAT HAD NOT BEEN PROPERLY PREPARED FOR PT PLACEMENT BY HILL-ROM PERSONAL. THE PT ALLEGEDLY HAD A PREEXISTING STAGE 1 PRESSURE ULCER IN HIS SACRUM AREA WHICH WAS RECLASSIFIED AS A STAGE 2 ULCER BY HOSP STAFF AFTER THE BAG WAS DISCOVERED IN THE MATTRESS. HILL-ROM'S TECH INSPECTED THE DEVICE AND FOUND NO OTHER ISSUES AND REMOVED IT FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAIR ECLIPSE LOW AIRLOSS THERAPY UNIT LOW AIRLOSS THERAPY INX HILL-ROM 90105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1