BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOLVO 7007 ES

    MDR report key: 5111283 · Received September 29, 2015

    Report

    Report Number
    8030916-2015-00118
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 3, 2015
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT WAS INSPECTED BY THE DISTRIBUTOR ((B)(4)). THE DISTRIBUTOR'S TECHNICIAN FOUND NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. THE NURSING ASSISTANT STATED THAT THE STRAP KINKED PRIOR TO THE LIFT, BUT SHE TURNED THE STRAP TO CORRECT THE KINK. IN THE INSTRUCTION GUIDE, 7EN140102-04 FOR GOLVO 7007 ES, IT IS STATED UNDER SAFETY INSTRUCTIONS: BEFORE LIFTING ALWAYS MAKE CERTAIN THAT: THE LIFT STRAP IS NOT TWISTED OR WORN AND THAT IT CAN MOVE FREELY IN AND OUT OF THE LIFT UNIT; LIFTING ACCESSORIES ARE NOT DAMAGED; THE LIFTING ACCESSORY IS CORRECTLY APPLIED TO THE LIFTING EQUIPMENT; A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS LIFT. THE LIFT'S DISTRIBUTOR ((B)(4)) PERFORMS PREVENTATIVE MAINTENANCE ON THE ACCOUNT'S LIFTS. HILL-ROM REQUESTED THE RETURN OF THE SLING BAR AND ATTACHMENTS FOR ADDITIONAL INVESTIGATION. THE PARTS HAVE BEEN RECEIVED AND THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    HILL-ROM HAS COMPLETED THE INVESTIGATION OF THE RETURNED PARTS AND ALL ITEMS WERE FULLY FUNCTIONING. HOWEVER, THE LIFT STRAP HAD SIGNS OF BEING REPEATEDLY USED WHILE TWISTED DURING LIFTING AND THE ALUMINUM HOOK PROFILE HAD SIGNS OF WEAR AND INDENTATION MARKS. THE INDENTATION MARKS ON THE QUICK RELEASE ALUMINUM HOOK CAN INDICATE THAT THE QUICK RELEASE HOOK (QRH) HAS NOT BEEN PROPERLY ATTACHED TO THE Q-LINK DURING LIFT. FOR PATIENT SAFETY, IT IS VERY IMPORTANT THAT THE CAREGIVERS FOLLOW THE INSTRUCTIONS GIVEN FROM HILL-ROM. HILL-ROM STATES IN (B)(4) "INSTRUCTION GUIDE UNIVERSAL SLINGBAR" THAT THE CAREGIVER SHALL ALWAYS, BEFORE LIFTING, MAKE CERTAIN THAT ¿THE LIFTING ACCESSORY IS CORRECTLY APPLIED TO THE LIFTING EQUIPMENT." TO ENSURE THIS, THERE ARE IMAGES SHOWING A CORRECTLY ATTACHED QRH IN THE UNIVERSAL SLINGBAR INSTRUCTION GUIDE. THIS LIFT STRAP HAS BEEN REPEATEDLY TWISTED DURING LIFTING WHICH IS NOT ACCORDING TO THE INSTRUCTION GUIDE OF (B)(4). HILL-ROM STATES THAT THE USER SHALL CHECK THE LIFT STRAP FOR WEAR AND MAKE SURE IT IS NOT TWISTED BEFORE LIFTING. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL -ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT DROPPED TO THE FLOOR AND LANDED ON HER BUTTOCKS WHILE BEING TRANSFERRED FROM THE BED. THE LIFT WAS LOCATED IN THE PATIENT ROOM AT THE ACCOUNT. THERE WAS NO INJURY REPORTED AND THE XRAYS DID NOT SHOW ANY FRACTURES. THE PATIENT WAS NOT TRANSFERRED TO THE HOSPITAL, BUT REMAINED IN THE CARE FACILITY PER THE FAMILY'S WISHES. PALLIATIVE CARE WAS PROVIDED INCLUDING MORPHINE FOR PAIN RELIEF. THE PATIENT DIED ON (B)(6) 2015, AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    HILL -ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT DROPPED TO THE FLOOR AND LANDED ON HER BUTTOCKS WHILE BEING TRANSFERRED FROM THE BED. THE LIFT WAS LOCATED IN THE PATIENT ROOM AT THE ACCOUNT. THERE WAS NO INJURY REPORTED AND THE XRAYS DID NOT SHOW ANY FRACTURES. THE PATIENT WAS NOT TRANSFERRED TO THE HOSPITAL, BUT REMAINED IN THE CARE FACILITY PER THE FAMILY'S WISHES. PALLIATIVE CARE WAS PROVIDED INCLUDING MORPHINE FOR PAIN RELIEF. THE PATIENT DIED ON (B)(6) 2015, AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643066 GOLVO 7007 ES NON-AC POWERED LIFT FSA LIKO AB P2000010

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Death