BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3458792 · Received November 8, 2013

    Report

    Report Number
    1525712-2013-09001
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    August 30, 2013
    Report Date
    October 18, 2013
    Manufacturer
    UNKNOWN
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LIMITED INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION CANNOT BE OBTAINED, NO CONTACT INFORMATION WAS SUPPLIED. IT IS UNKNOWN IF THIS IS AN INVACARE PRODUCT. STATES PRODUCT IS AN AC POWERED HOYER PATIENT LIFT (FNG). INVACARE ONLY DISTRIBUTES NON-AC POWERED PATIENT LIFTS ( HYDRAULIC OR BATTERY OPERATED - FSA). REPORT ALSO STATES THE SLING IS AN INVACARE COMPATIBLE SLING, NOT AN ACTUAL INVACARE SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING TRANSFERRED FROM THE BED TO A WHEELCHAIR USING AN UNKNOWN HOYER LIFT AND UNKNOWN MESH FULL BODY SLING W/COMMODE OPENING. DURING THE TRANSFER THE LEFT LEG STRAP ON THE SLING BROKE CAUSING THE PATIENT TO SLIDE OUT OF THE SLING ONTO THE FLOOR. PATIENT SUFFERED A SKIN TEAR TO THEIR LEFT ARM, REDDENED AREA ON LEFT CHEST AND COMPLAINED OF PAIN IN THE LEFT LEG, PATIENT WAS SENT TO THE HOSPITAL FOR EVALUATION AND NO FRACTURES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580101 NON AC-POWERED PATIENT LIFT 880.5510 FSA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other