BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER HPL 700 W/ HOYER SLING

    MDR report key: 2255167 · Received September 14, 2011

    Report

    Report Number
    2182305-2011-00025
    Event Type
    Other
    Date Received
    September 14, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR BY FACILITY, PER FACILITY A STAFF PERSON SUSTAINED A BACK INJURY WHILE TRANSFERRING A LARGER PT USING A 4 POINT SLING WITH THE (B)(4) LIFT. THE FACILITY REPORTED THAT ONE OF THE HOOKS ON THE SLING STARTED TO SLIP AND THE RESIDENT STARTED TO FALL DURING THE TRANSFER, THE "SPOTTING" CAREGIVER TRIED TO CATCH THE RESIDENT. THE RESIDENT, "SPOTTER" AND ONE OTHER STAFF PERSON WAS PRESENT. CAREGIVERS WERE USING A 4 POINT SLING IN THAT THEY THOUGHT THE SLINGS WERE INTERCHANGEABLE BETWEEN THE 4 POINT LIFTS AND THIS 6 POINT LIFT. THEY HAD NOT PREVIOUSLY HAD AN IN-SERVICE /TRAINING COMPLETED. MULTIPLE (B)(4) ATTEMPTS HAVE BEEN MADE OT OBTAIN "REASONABLY KNOWN" INFO. THIS INCLUDES A PT IDENTIFIER, AGE/DOB, GENDER, SLING MODEL USED AND /OR SEVERITY / CONFIRMATION OF INJURY, IF ANY. DESPITE SEVERAL ATTEMPTS THE FACILITY HAS NOT BEEN FORTHCOMING WITH "REASONABLY KNOWN" INFO. THE FACILITY REPORTED THAT THE LIFT AND SLING REMAINS IN USE. NO PRODUCT FAILURE, MALFUNCTION OR INADEQUATE DESIGN IS BEING CLAIMED. FACILITY STATES "NO PT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER HPL 700 W/ HOYER SLING PATIENT LIFT W/SLING FNG JOERNS HEALTHCARE HPL 700/ SLING

    Patients

    Seq Age Sex Outcome Treatment
    1