BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2508664 · Received March 29, 2012

    Report

    Report Number
    3004493922-2012-00063
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 28, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ROSE LIFT - SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 MONTHS OF AGE. 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 (B)(6) MALE, WHO IS (B)(6). THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED LIFT PULLED TO LEFT WHILE MOVING RESIDENT. MINOR 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 STAND UP LIFT

    Patients

    Seq Age Sex Outcome Treatment
    1 105 Other