BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER ELECTRIC LIFT

    MDR report key: 2181530 · Received July 18, 2011

    Report

    Report Number
    2182305-2011-00017
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 13, 2011
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY DSI, ONE OF THEIR CUSTOMERS (B)(6), PER FACILITIES CUSTOMER SERVICE CALL, (B)(6) REFERENCE AN INCIDENT THAT ALLEGEDLY INVOLVED THE LIFT. HE REPORTED THE FOLLOWING OCCURRED IN THE EVENING OF (B)(6) 2011; TWO C.N.A.'S WERE MOVING A RESIDENT FROM THE BED TO A WHEELCHAIR, WHEN PART OF THE LIFT CAME APART, AND THEY DROPPED THE RESIDENT INTO THE WHEELCHAIR. PRODUCT HAS BEEN TAKEN OUT OF SERVICE. PICTURES OF THE LIFT WERE SENT TO THE MANUFACTURER FOR REVIEW. PICTURES REVEALED ON THE 4 POINT CRADLE, THERE ARE 2 SWIVEL BOLTS / PINS IN THE HINGE, ONE ON EITHER SIDE OF THE CRADLE, WHERE THE STRAP HOOKS TO. ONE OF THE BOLTS SNAPPED OFF. AFTER CONVERSATION WITH THE (B)(6) NO INJURY TO THE RESIDENT WAS REPORTED DUE TO THE FAST RESPONSE OF THEIR AIDES; HOWEVER, THEY BELIEVE THIS COULD HAVE BECOME A SERIOUS ISSUE IF THE AIDES WERE NOT SO ATTENTIVE. (B)(4) AND (B)(4) ISSUED TO GET LIFT PARTS BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER ELECTRIC LIFT PATIET LIFTER FNG APEX HEALTHCARE MFG INC PRESENCE W/4PTWSCLP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other