BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLVO 7007 ES

    MDR report key: 17939285 · Received October 16, 2023

    Report

    Report Number
    8030916-2023-00068
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 16, 2023
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE GOLVO 7007 IS AN ELECTRONICALLY POWERED MOBILE LIFT INTENDED TO BE USED TO AID IN TRANSFERRING AND LIFTING PATIENTS. THE DEVICE CAN BE USED IN MOST LIFTING SITUATIONS: FOR EXAMPLE, BETWEEN BED/WHEELCHAIR, TO/FROM THE TOILET, IN BATH AND SHOWER, TO/FROM THE FLOOR, FOR WEIGHING PATIENT AND FOR HORIZONTAL LIFTING. AN INSPECTION OF THE DEVICE PERFORMED BY A HILLROM TECHNICIAN NOTED THAT THE GOLVO LIFT HAD BEEN USED IN COMBINATION WITH A LIKO BALEA SCAL' UP SCALE. A SLING CROSS-BAR 450 WITH QUICK-RELEASE HOOK(QRH) WAS ATTACHED TO THE SCALE VIA AN ADAPTOR 22 (P.N. 3156505). THIS IS AN APPROVED COMBINATION DESCRIBED IN THE LIKO BALEA SCAL' UP USER MANUAL (7EN161114 REV 3). THE TECHNICIAN ALSO NOTED THAT QRH RED PLASTIC CATCH WAS FOUND BROKEN IN ONE OF THE CORNERS THAT SHOULD ATTACH TO THE SCALE'S ADAPTOR. THE QRH (P.N. 3156508) OF THE SLING CROSS-BAR 450 WAS REPLACED. THE LIFT STRAP ALSO APPEARED DAMAGED AND WAS REPLACED AS PART OF THE SERVICE EVENT. NO OTHER MALFUNCTION WAS IDENTIFIED WITH THE LIFT. THE LIKO BALEA SCAL'UP USER MANUAL (7EN161114 REV. 3), IN REGARDS TO GOLVO MOBILE LIFT WITH QUICK-RELEASE ASSEMBLY, NOTES: "LIKO LIFTS EQUIPPED WITH (Q-LINK) QUICK FASTENER REQUIRE QUICK-RELEASE HOOK UNIVERSAL (P.N. 3156508), ADAPTER 8 MM (P.N. 2016502) AND ADAPTER 22 (P.N. 3156505)." THIS IS AN APPROVED COMBINATION DESCRIBED IN THE LIKO BALEA SCAL' UP USER MANUAL (7EN161114 REV 3). THE RED PLASTIC COMPONENT THAT WAS FOUND BROKEN IN THIS EVENT IS PART OF THE QUICK RELEASE HOOK CATCH, WHICH SERVES TO THE USER AS A GUIDE TO ATTACH THE SLINGBAR TO THE LIFT. THE SLING CROSS-BAR 450 USER MANUAL (7EN160125 REV. 3), IN THE CARE AND MAINTENANCE SECTION, STATES: "FOR TROUBLE-FREE USE, CERTAIN DETAILS SHOULD BE CHECKED BEFORE EACH USE: WHEN USING THE QUICK-RELEASE SYSTEM, CHECK THAT THE QUICK-RELEASE HOOK IS CORRECTLY ATTACHED TO THE LIFT AND SLING CROSS-BAR. BEFORE LIFTING, CHECK THAT THE LIFTING ACCESSORY HANGS VERTICALLY AND CAN MOVE FREELY." FURTHERMORE, A PREVIOUSLY PERFORMED ANALYSIS FOR THIS FAILURE EVIDENCED THAT THE QUICK-RELEASE HOOK ITSELF RETAINS ITS FUNCTIONALITY EVEN WITH A NON-FUNCTIONAL/DAMAGED RED QUICK-RELEASE PLASTIC CATCH. A BROKEN RED QUICK RELEASE PLASTIC DOES NOT CAUSE INCORRECT ATTACHMENT AND HENCE DOES NOT IN ITSELF IMPOSE RISK FOR PATIENTS OR CAREGIVERS WITH RESPECT TO UNINTENDED DETACHMENT. THERE CAN ONLY BE AN UNINTENDED DETACHMENT FROM THE LIFT'S Q-LINK, IF THE QUICK-RELEASE HOOK IS INCORRECTLY ATTACHED TO IT. IN THIS EVENT, THE INJURIES SUSTAINED BY THE STUDENT (LOCALIZED PAIN ON PALPATION ON RIGHT UPPER LIMB AND CERVICAL SPINE) DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, HOWEVER, THE SLIGHT TEMPORARY CONFUSION SUFFERED REPORTED IS CONSIDERED A TEMPORARY SERIOUS DETERIORATION IN THE STUDENT'S STATE OF HEALTH, WHICH CONCLUDES THAT A SERIOUS INJURY OCCURRED. ADDITIONALLY, BASED ON THE INFORMATION RECEIVED IT IS REASONABLE TO SUGGEST THAT THE REPORTED EVENT WAS LIKELY CAUSED BY A USE ERROR/MISUSE OF DEVICE (INCORRECT ATTACHMENT OF THE SLING BAR TO THE LIFT), AND UNLIKELY CAUSED BY A MALFUNCTION/DEFECT OF THE DEVICE. PREVENTION OF THIS TYPE OF EVENT IS OUTLINED IN THE IFU AS NOTED ABOVE. HILLROM IS REPORTING THIS USE ERROR AS IT RESULTED IN SEROUS INJURY.

    Description of Event or Problem · 0

    ON THE 22ND OF SEPTEMBER 2023 THE CUSTOMER REPORTED AN EVENT HAPPENED WITH A GOLVO LIFT DURING A TRANSFER. ON THE 2ND OF OCTOBER 2023 , HILLROM RECEIVED A USER REPORT FROM ANSM REGARDING THE SAME INCIDENT, WITH THE FOLLOWING DESCRIPTION OF THE EVENT: "DURING A LESSON ON THE USE OF TECHNICAL AIDS FOR TRANSFERS, WHILE A STUDENT IS PLACED AT A HEIGHT IN THE HARNESS, UNHOOKING THE FLAIL FROM THE SUSPENSION AXIS. THE STUDENT FELL ON HER BACK FROM A HEIGHT OF APPROXIMATELY 1.20 M. A PLASTIC PART OF THE RELEASE HOOK SEEMS BROKEN.." THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716369 GOLVO 7007 ES MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED FSA LIKO AB P2000010

    Patients

    Seq Age Sex Outcome Treatment
    1 Female