BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2250081 · Received September 15, 2011

    Report

    Report Number
    3004493922-2011-00004
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS ISSUED FOR THE RETURN OF THIS LIFT. THE MODEL 9805P LIFT USES OWNER MANUAL PART NO 1024492 REV E - 05/23/06. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNERS MANUAL. THE FOLLOWING WARNINGS PROVIDED ON PAGE 10 PAGE 10 - 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." THE WEIGHT OF THE PATIENT ON THE LIFT AT THE TIME THE ARM WAS BENT IS UNKNOWN. THE WEIGHT CAPACITY FOR MODEL 9805P IS 450 LBS IS STATED ON PAGE 10 THE OWNERS MANUAL STATES: "DO NOT EXCEED MAXIMUM WEIGHT LIMITATION OF THE PATIENT LIFT. THE WEIGHT LIMITATION FOR THE 9805 AND THE 9805P LIFTS IS 450 LBS." IT IS UNKNOWN IF THERE WAS ADDITIONAL LOADING ON THE LIFT. THE MODEL SLING USED ON THIS LIFT IS UNKNOWN. THE FOLLOWING SLING MODELS ARE FOUND ON PAGE 14. THEY ARE: "MODEL NOS. 9042, 9043, 9046 AND 9047 SLINGS". THE WARNING ON PAGE 32 STATES: "INVACARE SLINGS AND HARDWARE ARE MADE SPECIFICALLY FOR USE WITH INVACARE PATIENT LIFTS. FOR THE SAFETY OF THE PATIENT, DO NOT INTERMIX SLINGS AND PATIENT LIFTS OF DIFFERENT MANUFACTURERS." THE MAINTENANCE HISTORY OF THIS DEVICE IS UNKNOWN. 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."

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING LIFTED WHEN THE ARM ALLEGEDLY BENT. IT IS NOT KNOWN IF THE CONSUMER FELL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU 9805P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other