BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOERNS HEALTHCARE N170

    MDR report key: 3702674 · Received February 25, 2014

    Report

    Report Number
    3702674
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 25, 2014
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BED WAS PLACED WITH HEAD OF BED ELEVATED APPROX 45 DEGREES TO SUPPORT PT HEADS. DURING PT CARE PROCESSES, STAFF WERE NOT ABLE TO RELEASE BED TO FLATTEN INTO CPR POSITION. MULTIPLE ATTEMPTS TO RELEASE BED UTILIZING BOTH ELECTRONIC CONTROLS AND MANUAL CPR RELEASE FAILED TO RELEASE THE HEAD OF THE BED. KNEE-GATCH DID FLATTEN WHEN CPR RELEASE WAS UTILIZED. MULTIPLE STAFF FROM THE FLOOR AND FROM MAINTENANCE ATTEMPTED TO CHANGE THE POSITION OF THE BED UTILIZING THE INSTRUCTIONS PRINTED ON THE LAMINATED CARD ATTACHED TO THE BED WITHOUT SUCCESS. DUE TO STAFF AND MAINTENANCE PERSONNEL LIABILITY TO RELEASE TRAPEZE ATTACHED TO THE BED UTILIZING ATTACHMENT PINS, MAINTENANCE STAFF CUT THE TRAPEZE OFF THE BED TO UNABLE STAFF TO GET THE BED OUT OF THE ROOM DURING THE PROCESS OF TRANSFERRING THE PT. PROBLEM IDENTIFIED: THERE IS NO INFO ON THE BED FOR CONTACT WITH THE BED MANUFACTURER. RENTAL COMPANY REPRESENTATIVES ATTEMPTED TO HELP WITH THE ISSUE BUT WERE NOT KNOWLEDGEABLE ENOUGH TO RESOLVE THE PROBLEM. THERE WERE A SIGNIFICANT NUMBER OF ATTEMPTS BY BOTH CLINICAL AND MAINTENANCE STAFF, AND MAINTENANCE STAFF WORKING UNDER THE DIRECTION OF THE RENTAL COMPANY REP TO UTILIZE DIRECTIONS ON THE LAMINATED CARD ATTACHED TO THE BED TO CORRECT THE PROBLEM WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116672 JOERNS HEALTHCARE N170 BARIATRIC BED OSI JOERNS HEALTHCARE BAR110A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other