BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2214786 · Received August 17, 2011

    Report

    Report Number
    1525712-2011-00442
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    December 1, 2008
    Report Date
    August 15, 2011
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. MODEL 9805, SERIAL NUMBER (B)(4). USER MANUAL PN 1024492. THE FOLLOWING INFORMATION IS PROVIDED TO THE CONSUMER TO HELP PREVENT THE OCCURRENCE OF BROKEN PARTS ON THE DEVICE WHILE IN USE. IT IS UNKNOWN IF THE USER FULLY READ AND UNDERSTANDS THE USERS MANUAL. ON PAGE 10 A WARNING: "GENERAL GUIDELINES CONTAINS IMPORTANT INFORMATION FOR THE SAFE OPERATION AND USE OF THIS PRODUCT. DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR." IT IS UNKNOWN IF THE CORRECT SLING WAS IN USE AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE USER CHECKED THE ATTACHMENTS PRIOR TO USE AND FOLLOWED THE COLOR CODING REQUIREMENTS. ON PAGE 11 IT STATES: "USE AN INVACARE APPROVED SLING THAT IS RECOMMENDED BY THE INDIVIDUAL'S DOCTOR, NURSE OR MEDICAL ASSISTANT FOR THE COMFORT AND SAFETY OF THE INDIVIDUAL BEING LIFTED." "BE SURE TO CHECK THE SLING ATTACHMENTS EACH TIME THE SLING IS REMOVED AND REPLACED TO ENSURE THAT IT IS PROPERLY ATTACHED BEFORE THE PATIENT IS REMOVED FROM A STATIONARY OBJECT (BED, CHAIR OR COMMODE)." " WHEN CONNECTING SLINGS EQUIPPED WITH COLOR CODED STRAPS TO THE PATIENT LIFT, THE SHORTEST OF THE STRAPS MUST BE AT THE BACK OF PATIENT FOR SUPPORT. USING LONGER STRAPS WILL LEAVE LITTLE OR NO SUPPORT FOR PATIENT'S BACK. THE LOOPS OF THE SLING ARE COLOR CODED AND CAN BE USED TO PLACE PATIENT IN VARIOUS POSITIONS. "WHEN THE SLING IS ELEVATED A FEW INCHES OFF THE SURFACE OF THE BED AND BEFORE MOVING THE PATIENT, CHECK AGAIN TO MAKE SURE THAT THE SLING IS PROPERLY CONNECTED TO THE HOOKS OF THE SWIVEL BAR. IF ANY ATTACHMENTS ARE NOT PROPERLY IN PLACE, LOWER THE PATIENT BACK ONTO THE STATIONARY SURFACE AND CORRECT THIS PROBLEM - OTHERWISE, INJURY OR DAMAGE MAY OCCUR." THIS DEVICE IS APPROXIMATELY 4 YEARS OLD. IT IS UNKNOWN IF THE USERS HAS BEEN PERIODICALLY CHECKING FOR WEAR. ON PAGE 12 IT STATES: "BE SURE TO CHECK THE SLING ATTACHMENTS EACH TIME THE SLING IS REMOVED AND REPLACED, TO ENSURE THAT IT IS PROPERLY ATTACHED BEFORE THE PATIENT IS REMOVED FROM THE BED OR CHAIR." "AFTER THE FIRST YEAR OF USE, THE HOOKS OF THE SWIVEL BAR AND THE MOUNTING BRACKETS OF THE BOOM SHOULD BE INSPECTED EVERY THREE MONTHS TO DETERMINE THE EXTENT OF WEAR. IF THESE PARTS BECOME WORN, REPLACE THEM IMMEDIATELY." "REGULAR MAINTENANCE OF PATIENT LIFTS AND ACCESSORIES IS NECESSARY TO ASSURE PROPER OPERATION." IT IS UNKNOWN IF THE USER CHECKS FOR NORMAL WEAR AND TEAR ON THE DEVICE. PAGES 42 AND 43 COVER WEAR AND TEAR AND INSPECTION OF THE PARTS. ON PAGE 42 IT STATES: WEAR AND DAMAGE: IT IS IMPORTANT TO INSPECT ALL STRESSED PARTS, SUCH AS SLINGS, SPREADER BAR AND ANY PIVOT FOR SLINGS FOR SIGNS OF CRACKING, FRAYING, DEFORMATION OR DETERIORATION. REPLACE ANY DEFECTIVE PARTS IMMEDIATELY AND ENSURE THAT THE LIFT IS NOT USED UNTIL REPAIRS ARE MADE. ALL SLING METAL PARTS SHOULD BE INSPECTED EVERY THREE MONTHS, AND IF WEAR IS APPARENT, REPLACEMENT MUST BE MADE. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY. ON PAGE 43 A CHART IS PROVIDED FOR SLINGS AND HARDWARE INSPECTION INTERVALS. THE CHART PROVIDES THE FOLLOWING FOR METAL CHAINS, S HOOKS , O-RINGS AND D RINGS. INSPECT "CHAINS, S-HOOKS, O-RINGS AND D-RINGS EACH TIME IT IS USED TO ENSURE PROPER CONNECTION AND PATIENT SAFETY. INSPECT SLING ATTACHMENTS AND MATERIAL FOR WEAR. INSPECT NYLON WEB STRAPS FOR WEAR." INITIALLY - AT SET-UP. INSTITUTIONAL INSPECT/ADJUST MONTHLY. IN-HOME INSPECT/ADJUST MONTHLY.

    Description of Event or Problem · 1

    THE CAREGIVER ASSEMBLED THE LIFT AND PUT THE CONSUMER IN THE SLING. AS SHE BEGAN MOVING THE CONSUMER, ONE OF THE METAL CLIPS ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL TO THE FLOOR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG LAND AMERICA HEALTH & FITNESS 9805

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other