BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2393273 · Received December 30, 2011

    Report

    Report Number
    3004493922-2011-00067
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Report Date
    March 29, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #3004493922-011-0067. LIFT, MODE # ROZE, SERIAL #(B)(4) WAS RETURNED FOR AN EVALUATION. PRODUCT WAS APPROXIMATELY 2 YEARS OLD AT THE TIME OF THE INCIDENT. MAINTENANCE HISTORY IS UNKNOWN. ENGINEERING STATED THAT THE LIFT ARM WAS BENT DUE TO SEVERE LOADING. THE HANDLE GRIP TUBE ON THE LIFT ARM WAS ALSO BROKEN OFF. THIS TYPE OF DAMAGE IS NOT TYPICAL UNDER NORMAL USE CONDITIONS. THE EXACT FORM OF ABUSE IS UNKNOWN, BUT THIS DAMAGE CAN OCCUR WHEN THE LIFT WAS RAISED WITH THE LEFT ARM RESTRAINED. IT COULD HAVE BEEN STRAPPED TO THE LEG BY THE SLING. IT MAY ALSO HAVE BEEN TRAPPED UNDER A LEDGE AND RAISED. THESE COULD CAUSE THE HANDLE WELD TO BREAK AND THE ARM TO YIELD. THIS INCIDENT IS MOST LIKELY DUE TO USER ERROR. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ROZE SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE USER MANUAL PART NUMBER 1150703 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ROZE SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE USER MANUAL PART NUMBER 1150703 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    SLING HOOKUP ALLEGEDLY BROKE AT WELD. USER BELIEVES THAT THE NURSING ASSISTANT ATTACHED THE SLING AT THE WRONG PART OF THE LIFT AND CAUSED IT TO ALLEGEDLY BREAK. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    SLING HOOKUP ALLEGEDLY BROKE AT WELD. USER BELIEVES THAT THE NURSING ASSISTANT ATTACHED THE SLING AT THE WRONG PART OF THE LIFT AND CAUSED IT TO ALLEGEDLY BREAK. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other