BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT SUPPLY

    MDR report key: 6770727 · Received August 7, 2017

    Report

    Report Number
    2438477-2017-00019
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    January 26, 2017
    Report Date
    January 30, 2017
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTIFICATION REGARDING AN INCIDENT AT THE (B)(6) INVOLVING A PATIENT LIFT THAT (B)(4) IMPORTS AND DISTRIBUTES FOR A PRIVATE LABEL CUSTOMER, DIRECT SUPPLY . THE PATIENT WAS BEING LOWERED FROM THE PATIENT LIFT BY TWO CERTIFIED NURSING ASSISTANTS, WHEN ALLEGEDLY THE LEFT SIDE SLING LOOP SLIPPED OUT OF THE LIFT HOOK CAUSING HER TO FALL 2-3 FEET TO THE FLOOR. THE PATIENT WAS TAKEN TO THE ER WHERE THE INITIAL DIAGNOSIS SHOWED A FRACTURED RIGHT FEMUR HOWEVER, IT LEAD TO AN (B)(6) CONFIRMED THE SLING WAS NOT RIPPED AND THE LIFT HOOKS WERE NOT BROKEN. ACCORDING TO ENGINEERS AT (B)(6), THEY DISCOVERED THAT THE HOOK CLIP WAS NOT FUNCTIONING PROPERLY THEREFORE THE SLING LOOP MAY HAVE SLIPPED OUT. DRIVE HAS REQUESTED THE PATIENT LIFT FOR INTERNAL EVALUATION BUT WAS DECLINED BECAUSE (B)(6) DOES NOT WANT TO RELEASE THE ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551778 DIRECT SUPPLY PATIENT LIFT FSA APEX HEALTH CARE MFG., INC. DS-13242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization