BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2123149 · Received June 9, 2011

    Report

    Report Number
    1525712-2011-00252
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    June 9, 2011
    Manufacturer
    INVACARE
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER ALLEGEDLY FELL DURING A TRANSFER. CAREGIVER ATTEMPTED TO BREAK CONSUMER'S FALL. LIFT WAS APPROXIMATELY 16 YEARS OLD AT TIME OF INCIDENT. MAINTENANCE HISTORY IS UNKNOWN. SCHOOL AND DEALER ATTRIBUTED INCIDENT TO CAREGIVER BUMPING THE LEG ADJUSTMENT LEVER DURING THE TRANSFER. CAREGIVER ALLEGED LEGS ON LIFT BUCKLED. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    THE CONSUMER AND CAREGIVER WERE BOTH ALLEGEDLY INJURED WHEN THE LIFT ALLEGEDLY COLLAPSED. THE CONSUMER WAS BEING TRANSFERRED FROM THE TOILET TO A WHEELCHAIR, WHEN THE LEGS ON THE LIFT ALLEGEDLY BUCKLED, CAUSING THE CONSUMER TO FALL. THE CAREGIVER ALLEGES SHE WAS INJURED WHEN SHE ATTEMPTED TO STOP THE CONSUMER FROM FALLING. THE CONSUMER AND CAREGIVER BOTH SOUGHT MEDICAL ATTENTION. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE 9800A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention