BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI SKY 600

    MDR report key: 6833442 · Received August 31, 2017

    Report

    Report Number
    9681684-2017-00067
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER (B)(4). ARJOHUNTLEIGH RECEIVED INFORMATION ABOUT AN ISSUE WHICH OCCURRED INVOLVING A MAXI SKY 600 CEILING LIFT. IT WAS REPORTED THAT THE CAREGIVER WAS TRYING TO LOWER THE CEILING LIFT SPREADER BAR IN ORDER TO TRANSFER A RESIDENT FROM BED TO CHAIR. THE LIFT WOULD NOT LOWER ENOUGH USING THE HAND CONTROL SO THE CAREGIVER MANUALLY TRIED TO LOWER THE SPREADER BAR, AS A RESULT, SHE HAS BACK STRAIN. PLEASE BE AWARE THAT OUTCOME FOR THE CAREGIVER IS BEING CONSIDERED A SERIOUS INJURY DUE TO ADDITIONAL INFORMATION STATING THAT THE CAREGIVER REQUIRED PHYSIOTHERAPY. THE CUSTOMER WAS VISITED BY THE ARJOHUNTLEIGH REPRESENTATIVE TO PERFORM THE DEVICE EVALUATION. THERE WAS NO ISSUE FOUND REGARDING FUNCTIONALITY OF THE DEVICE. IT WAS CONFIRMED THAT THE HI/LOW FUNCTIONS OF THE MAXI SKY 600 CEILING LIFT WORKED ACCORDING TO THE MANUFACTURER SPECIFICATION. ANY STUCK WAS NOT OBSERVED, IT WAS POSSIBLE TO LOWER THE SPREADER BAR TO THE GROUND. DURING AN INTERVIEW WITH THE CUSTOMER, IT WAS CLARIFIED THAT THE INCIDENT OCCURRED DUE TO USER ERROR CAUSED BY AN INSUFFICIENT KNOWLEDGE ABOUT THE DEVICE. IT WAS DETERMINED AND AGREED UPON BY THE EXECUTIVE DIRECTOR THAT THE STAFF PERSON INVOLVED NEEDED TO BE RETRAINED IN THE USE OF THE LIFT SO RE-TRAINING HAS BEEN COMPLETED. PLEASE NOTE, THAT IN THE LABELING, THERE IS A PARTICULAR ATTENTION TO THE RESPONSIBILITY OF THE DEVICE OWNER TO MAKE SURE THAT THE DEVICE USERS ARE TRAINED AND KNOWLEDGEABLE OF THE CONTENTS OF THE LABELING AND CORRECT LIFTING PROCEDURES. THE INSTRUCTION FOR USE (IFU) DELIVERED WITH EACH CEILING LIFT DEVICE PROVIDES SAFETY INSTRUCTIONS AND WARNINGS REGARDING: HOW TO USE THE MAXI SKY 600. IT CLEARLY DESCRIBES STEP BY STEP HOW TO PERFORM THE TRANSFER. WHEN THE IFU WOULD HAVE BEEN FOLLOWED THE EVENT WOULD HAVE BEEN AVOIDED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS REGISTERED IN THE LAST FIVE YEARS FOR MAXI SKY 600 AND SIMILAR CEILING LIFTS, WE HAVE NOT FOUND ANY CASES WITH THE SAME OR A SIMILAR DESCRIPTION. THE ISSUE CLAIMED BY THE CUSTOMER, IN THIS CASE, APPEARS TO BE AN ISOLATED OCCURRENCE. TO SUM UP, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. DUE TO ALLEGATION THAT THE DEVICE STOPPED WORKING DURING THE USE, THE SYSTEM WAS NOT UP TO SPECIFICATION AT THE TIME OF THE INCIDENT. PLEASE BE AWARE THAT THE LIFT WAS INSPECTED BY ARJOHUNTLEIGH REPRESENTATIVE. THERE WAS NO ISSUE FOUND REGARDING FUNCTIONALITY OF THE DEVICE. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES DUE TO THE REPORTED OUTCOME (THE STRAIN OF A CAREGIVER'S BACK REQUIRED PHYSIOTHERAPY).

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED INFORMATION ABOUT AN ISSUE WHICH OCCURRED INVOLVING A MAXI SKY 600 CEILING LIFT. IT WAS REPORTED THAT THE CAREGIVER WAS TRYING TO LOWER THE CEILING LIFT SPREADER BAR IN ORDER TO TRANSFER A RESIDENT FROM BED TO CHAIR. THE LIFT WOULD NOT LOWER ENOUGH USING THE HAND CONTROL SO THE CAREGIVER MANUALLY TRIED TO LOWER THE SPREADER BAR, AS A RESULT, SHE HAS BACK STRAIN. PLEASE BE AWARE THAT OUTCOME FOR THE CAREGIVER IS BEING CONSIDERED A SERIOUS INJURY DUE TO ADDITIONAL INFORMATION STATING THAT THE CAREGIVER REQUIRED PHYSIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615814 MAXI SKY 600 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. LD10009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention