BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT SUPPLY

    MDR report key: 6438408 · Received March 28, 2017

    Report

    Report Number
    3010605276-2017-00001
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    January 26, 2017
    Report Date
    March 27, 2017
    Manufacturer
    APEX HEALTH CARE MFG.,INC
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DESCRIPTION AND PHOTOS PROVIDED FROM (B)(4), WE JUDGE THIS INCIDENT WAS CAUSED BY IMPROPER USE OF CAREGIVERS. THE CAREGIVERS MIGHT NOT PUT STRAP OF THE SLING INTO THE HOOK FULLY AND PROPERLY, OR JUST HANG THE STRAP ON THE TOP OF THE HOOK INSTEAD INTO THE HOOK. THIS IS THE ONLY POSSIBILITY THE SLING MIGHT SLIDE OFF THE HOOK. WE CAREFULLY INSPECT THE HOOK DESIGN, AS LONG AS THE STRAP IS FULLY LOADED IN HOOK, EVEN THERE IS A SMALL GAP BETWEEN THE CLIP AND HOOK, THE SLING MIGHT ONLY MOVE IN TOWARD TO PATIENT LIFT DUE TO THE GRAVITY. THE SLING WON'T SLIDE OUT THE HOOK. ALSO, THE SLING WAS NOT RIPPED AND LIFT HOOK WERE NOT BROKEN, WHICH PROVEN OUR JUDGEMENT. BY THE WAY,THE CAREGIVER SHOULD ALWAYS LOOK AT THE RESIDENT CAREFULLY WHEN RAISING UP THE LIFT, IF THE CAREGIVER DID THE ABOVE BEHAVIOR,THE ACCIDENT MIGHT NOT HAPPEN.

    Description of Event or Problem · 1

    WE RECEIVED FORM 2500A REPORT#(B)(4) ON FEB 27 2017. THIS EVENT WAS DESCRIBED BY OUR CUSTOMER ((B)(4)) OF USA AS BELOW: THE PATIENT WAS BEING LOWERED FROM 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 SHOWED A FRACTURED RIGHT FEMUR. HOWEVER, IT LEAD TO AN AMPUTATION SINCE THE PATIENT WAS ALREADY BATTLING AN INFECTION IN THE SAME LEG. (B)(6) FROM (B)(6) CONFIRMED THE SLING WAS NOT RIPPED AND THE LIFT HOOKS WERE NOT BROKEN. ACOORDING 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
    221622 DIRECT SUPPLY LIFT, PATIENT LIFT, AC-POWERED, FNG APEX HEALTH CARE MFG.,INC DS-13242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization