BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARI-BREEZE

    MDR report key: 2894406 · Received December 27, 2012

    Report

    Report Number
    1000381138-2012-00011
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION ((B)(4)) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR (ARJO LTD (B)(4)). AFTER REVIEWING THE DETAILS SURROUNDING THIS EVENT, IT WAS ESTABLISHED THAT THE BED FRAME WHILST UNDER PRESSURE FAILED TO SUPPORT THE PT. THIS CAUSED A MALFUNCTION (BEND) TO OCCUR AND ALLOWED THE PT TO FALL TO THE GROUND. WE ARE NOT THE MFRS OF THE BED FRAME (VARITECH), HOWEVER, WE HAVE REPORTED THE EVENT DUE TO OUR PRODUCT (BARI-BREEZE SYSTEM) ALSO BEING USED AT THE TIME OF THE INCIDENT. THE EVENT DESCRIPTION SUGGESTED THAT THE PT SAT UP ON THE EDGE OF THE BED AND THE MATTRESS SUNK. THE MATTRESS IS AN AIR FILLED SYSTEM THAT WHEN INSTALLED CORRECTLY WITH ITS AIR FILLED SIDE BOLSTERS, WOULD FULLY SUPPORT A PT AND PREVENTS THEM FROM INADVERTENTLY EXITING THE BED. OUR CURRENT IFU ALSO WARNS AND USER THAT THE BARI-BREEZE SYSTEM MUST BE INSTALLED ON BED FRAMES THAT ARE EQUIPPED WITH SAFETY SIDES. WE ALSO ADVISE THAT THE SAFETY SIDES ARE RAISED AND LOCKED IN POSITION AFTER THE PT IS ON THE MATTRESS. WE CANNOT CONFIRM IF THE INSTALLATION PROCEDURE WAS CARRIED OUT IN ACCORDANCE WITH OUR INSTRUCTIONS, HOWEVER THE MALFUNCTION THAT OCCURRED WITH THE BED FRAME MAY STILL HAVE CAUSED THE PT TO FALL EVEN WITH THE MATTRESS INSTALLED CORRECTLY. AFTER A REVIEW OF OUR POST MARKET SURVEILLANCE DATA, IN THE LAST 5 YEARS, THERE HAS BEEN NO INSTANCES OF ANY REPORTABLE EVENTS RELATING TO THE BARI-BREEZE MATTRESS SYSTEM. THE MATTRESS SYSTEM INVOLVED IN THIS EVENT WAS FUNCTION TESTED AND ALL FUNCTIONS WORKED AS PER ITS INTENDED USE. WE COULD FIND NO PROBLEM WITH OUR SYSTEM. WE TAKE ALL ISSUES OF THIS NATURE SERIOUSLY AND WILL CONTINUE TO MONITOR ANY FUTURE TRENDS THAT MAY ARISE FROM THE USER OF OUR PRODUCTS, HOWEVER, BASED ON THE INFO PROVIDED TO US, WE BELIEVE THE CONTRIBUTING FACTOR IN THE PT'S FALL WAS THE MALFUNCTION OF THE BED FRAME (3RD PARTY MFR).

    Description of Event or Problem · 1

    IN LINE WITH OUR (MFRS) SERVICE TECH'S INCIDENT DESCRIPTION: "STAFF HEARD RESIDENT YELLING FOR HELP, STAFF ENTERED ROOM AND FOUND RESIDENT LAYING FACE DOWN ALONG SIDE OF HER BED. RESIDENT STATED THAT SHE SAT UP ON THE EDGE OF THE BED AND THE MATTRESS SUNK AND SHE FELL TO THE FLOOR. RESIDENT ASSISTED UP TO WHEEL CHAIR WITH TENOR LIFT AND 6 STAFF MEMBERS. ACCORDING TO STAFF INTERVIEWED, THE PLATFORM EXTENSIONS SLID BACK WHEN RESIDENTS LEGS CAME IN CONTACT WITH THEM, CAUSING ALL HER WEIGHT TO BE DIRECTED TO RIGHT FRONT SIDE BOARD, CAUSING IT TO BEND PRIOR TO HER FALLING TO THE FLOOR"; NOT HOSPITALIZED AND NO ER VISIT. NOTE: THE BED FRAME IN QUESTION (VARITECH) IS NOT ONE OF OUR PRODUCTS, ONLY THE MATTRESS SYSTEM FITTED TO THE BED IS OURS (BARI-BREEZE). ORIGINALLY, IT WAS ONLY REPORTED THAT A VARITECH BEDFRAME WAS INVOLVED; HOWEVER, IT WAS LATER DETERMINED AFTER RECEIVING IDF THAT A BARI-BREEZE WAS BEING USED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARI-BREEZE PAC FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB BARIB MRS48

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR