BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 8145752 · Received December 10, 2018

    Report

    Report Number
    9681684-2018-00099
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 10, 2018
    Report Date
    January 9, 2018
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012068 BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018 ARJO HAS BEEN NOTIFIED ABOUT THE EVENT, WHICH OCCURRED IN ALLINGTON COURT CARE HOME - BUPA IN ST ALBANS (UK). BASIS OF THE CUSTOMER ALLEGATION, THE EVENT OCCURRED DURING THE TRANSFER OF THE RESIDENT FROM THE BED TO THE CHAIR WITH THE PARTICIPATION OF THE MAXI MOVE PASSIVE FLOOR LIFT AND PASSIVE CLIP SLING. WHEN THE LIFT WAS REVERSED AND TURNED TO LEFT, THE RESIDENT FELL TO THE FLOOR. AS A CONSEQUENCE, THE RESIDENT SUSTAINED LACERATION REQUIRING SUTURES. AFTER THIS EVENT, ARJO REPRESENTATIVE VISITED THE FACILITY TO CONDUCT THE INSPECTION OF THE INVOLVED SYSTEM. THE INVOLVED MAXI MOVE WAS UNDER THE ARJO SERVICE CONTRACT AND THE LAST SERVICE WAS PERFORMED ON (B)(6) 2018. THE LIFT WAS IN OVERALL GOOD CONDITION. THE INTERVIEW WITH THE FACILITY STAFF REVEALED THAT THE LEFT SHOULDER CLIP UNHOOKED FROM THE SPREADER BAR'S PIN (THE COMPONENT ON WHICH THE SLING'S CLIP IS ATTACHED ON). THE TECHNICIAN TRIED TO RECREATE THE EVENT AND IT WAS CONFIRMED THAT DURING ATTACHING OF THE CLIP, THERE WAS NO RESISTANCE AND NO FORCE WAS NEEDED TO ATTACH THE CLIP. THE CLIP COULD DETACH EASILY FROM THE SPREADER BAR AS HAPPENED DURING THE TRANSFER. THIS OBSERVATION COULD NOT BE DUPLICATED ONCE THE DEVICE WAS TESTED WITH THE USE OF OTHER ARJO CLIP SLINGS (NOT INVOLVED IN THE COMPLAINT).THE SYSTEM REPRESENTED THE RESISTANCE ONCE THE SLING CLIP WAS APPLIED ON THE SPREADER BAR'S PIN - AS EXPECTED PER SPREADER BAR AND SLING CLIP DESIGN. THIS SIMULATION CONFIRMED THAT THE PROBLEM WAS ON THE SLING SIDE. THE INSTRUCTION FOR USE DEDICATED TO THE PASSIVE CLIP SLINGS (04.SC.00-INT1_2) INCLUDES DETAILED INFORMATION REGARDING THE APPLICATION OF THE SLING: - "SLIGHTLY LIFT THE RESIDENT TO CREATE TENSION IN THE SLING." - "TO AVOID RESIDENT FROM FALLING, MAKE SURE THAT THE SLING ATTACHMENTS ARE ATTACHED SECURELY BEFORE AND DURING THE LIFTING PROCESS." IN THE SITUATION, WHEN THE SLING'S CLIP IS ATTACHED TO THE SPREADER BAR AND THE POSITION OF THE CLIPS IS MONITORED TO STAY IN PLACE ACCORDING TO THE INFORMATION MENTIONED ABOVE, THERE IS A VERY LOW POSSIBILITY OF THE HAZARDOUS SITUATION. BASED ON THE ABOVE-MENTIONED INFORMATION, IT CAN BE CONCLUDED THAT THE SERIES OF CIRCUMSTANCES COULD CONTRIBUTE TO THE EVENT. BASED ON THE CONDUCTED SIMULATION, THE DEFECTIVE SLING'S CLIP WHICH COULD EASILY DETACHED FROM THE SPREADER BAR COULD BE THE MAIN FACTOR CONTRIBUTING TO THE EVENT. DUE TO THE INSUFFICIENT INFORMATION, THE EXACT CAUSE OF THE CLIP ISSUE COULD NOT BE ESTABLISHED. ADDITIONALLY IT CAN BE CONCLUDED THAT THE CAREGIVER DID NOT FOLLOW SAFETY TRANSFER PROCEDURE INCLUDED IN THE INSTRUCTION FOR USE WHICH CAUSED THAT THE PROBLEM WAS NOT DETECTED BEFORE THE START OF THE TRANSFER. REVIEW OF SIMILAR REPORTABLE EVENTS FOR THE MAXI MOVE PASSIVE FLOOR LIFT AND SIMILAR DEVICES REVEALED A NUMBER OF CASES RELATED TO THIS TYPE OF EVENT: CLIP SLING DETACHMENT DURING TRANSFER WERE FOUND. IN SUMMARY, THE MAXI MOVE PASSIVE FLOOR LIFT AND THE CLIP SLING WERE BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. DURING EVALUATION CONDUCTED BY ARJO REPRESENTATIVE, IT WAS CONFIRMED THAT THE SLING DID NOT MEET THE MANUFACTURER'S SPECIFICATION DURING THE EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES BECAUSE THE RESIDENT SUSTAINED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE RESIDENT WAS BEING TRANSFERRED FROM THE BED TO THE CHAIR USING A MAXIMOVE HOIST AND ALL DAY SLING. THE RESIDENT WAS LIFTED FROM BED HOIST WAS REVERSED AND TURNED TO LEFT IN ONE MOTION, AS THIS WAS PERFORMED THE RESIDENT FALL ON THE FLOOR AND SUSTAINED INJURIES. FACILITY STAFF CHECKED HOIST AND SLING AFTER THE EVENT AND SAW THE LEFT SHOULDER SLING CLIP HAS BECOME DISLODGED FROM THE LIFT HANGERBAR. THE PATIENT SUSTAINED A SMALL LACERATION TO THE PARIETAL REGION ( BACK LOWER HEAD SIDE OF NECK). THE SUTURES HAS BEEN USED AS A TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985634 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention