BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI TWIN

    MDR report key: 6040216 · Received October 19, 2016

    Report

    Report Number
    3007420694-2016-00218
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 18, 2016
    Report Date
    September 20, 2016
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. ARJOHUNTLEIGH IS IN PROCESS OF GATHERING MORE INFORMATION ABOUT THIS PARTICULAR INCIDENT. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT (H1) NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#(B)(4)) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#(B)(4)). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS PERFORMED BASED ON THE VERY LIMITED INFORMATION REPORTED BY THE CUSTOMER FACILITY. ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER USING PASSIVE LIFT (MAXI TWIN) AND THE SLING, THE RESIDENT FELL DOWN. NO MALFUNCTIONS REGARDING THE LIFT NOR ACCESSORIES WERE INDICATED BY THE CUSTOMER. IN ORDER TO UNDERSTAND THE CIRCUMSTANCES OF THE ISSUE BETTER AND CONFIRM THE INITIAL INFORMATION RECEIVED, ARJOHUNTLEIGH WAS TRYING TO ARRANGE A CUSTOMER SITE VISIT. DESPITE OUR BEST EFFORT, THE CUSTOMER REFUSED TO REVEAL FURTHER INFORMATION ABOUT THIS INCIDENT AND DID NOT GIVE ARJOHUNTLEIGH A PERMISSION TO INSPECT THE MAXI TWIN DEVICE. IN RESPECT TO THE LIMITED NATURE OF THIS INFORMATION, WE WERE LEFT TO REVIEW VERY LIMITED INFORMATION RECEIVED AND COMPARE IT TO OUR PRODUCT KNOWLEDGE, PER OUR BEST EFFORTS. THE COMPLAINT DESCRIPTION SUGGEST THAT LIFT CAUSED OR CONTRIBUTED TO THE RESIDENT'S FALL. IN REFERENCE TO OUR BEST PRODUCT KNOWLEDGE, THE SUGGESTED INDICATION SEEMS TO BE INCORRECT, FOR THE FOLLOWING REASONS: 1.PATIENT SUPERVISION. ACCORDING TO THE DEVICE INSTRUCTION FOR USE (04.KT.00), MAXI TWIN DEVICE SHALL ALWAYS BE HANDLED BY A TRAINED CAREGIVER, CONTINUOUSLY ATTENDING THE RESIDENT. "TO AVOID INJURY, MAKE SURE THAT THE RESIDENT IS NOT LEFT UNATTENDED AT ANY TIME (...)" - PAGE 6. 2. ANOTHER FACTOR THAT SHOULD BE POINTED OUT IS SLING ATTACHMENT. ONCE THE SLING IS ATTACHED CORRECTLY THE RESIDENT CAN BE PARTIALLY SUSPENDED UNDER THEIR ARMPITS BY THE SLING WHAT ALLOWS RESIDENT TO BE TRANSFERRED IN A SAFE AND COMFORTABLE WAY. DEVICE INSTRUCTION FOR USE INCLUDES MULTIPLE SAFETY INSTRUCTIONS REFERRING TO THE USAGE OF THE SLING ACCESSORY. "TO AVOID THE RESIDENT FROM FALLING OR CAREGIVER FROM BEING INJURED, ONLY DETACH THE SLING CLIPS WHEN THE RESIDENT'S BODY WEIGHT IS FULLY SUPPORTED BY THE BED OR CHAIR" - PAGE 12. 3. INTENDED USE OF THE DEVICE AS DESCRIBED IN THE IFU IS THAT IT IS INTENDED TO BE USED FOR LIFTING AND TRANSFERS IN HOSPITALS, NURSING HOMES, OR OTHER HEALTH CARE FACILITIES. THE MAXI TWIN MAY ONLY BE USED BY APPROPRIATELY TRAINED CAREGIVERS WITH ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT AND ITS COMMON PRACTICES AND PROCEDURES. "(...) MAXI TWIN IS INTENDED TO BE USED FOR RESIDENT WHO IS DEPENDENT ON THE CAREGIVER IN MOST SITUATIONS (...)" - PAGE 5. 4. THE DEVICE'S WORKING CONDITION. AS PER DEVICE INSTRUCTION FOR USE, THE SERVICE AND MAINTENANCE OF THE DEVICE MUST BE PERFORMED ACCORDING TO THE SCHEDULE INDICATED IN THE IFU TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION. INITIAL INFORMATION REPORTED TO ARJOHUNTLEIGH SSU DOES NOT INCLUDE ANY INFORMATION OR INDICATION THAT THE DEVICE HAD FAILED. THE LIMITED INFORMATION AND LACK OF POSSIBILITY TO GATHER MORE INFORMATION UNFORTUNATELY DOES NOT ALLOW US TO ESTABLISH WHETHER THE DEVICE ACTUALLY MALFUNCTIONED OR NOT. "THE MAXI TWIN IS SUBJECT TO WEAR AND TEAR, AND THE FOLLOWING ACTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION - PAGE 40". IT HAS TO BE EMPHASIZED THAT MAXI TWIN DEVICE HAS BEEN DESIGNED, PRODUCED AND CERTIFIED TO PROVIDE SAFE AND EFFICIENT HANDLING, INCLUDING SAFETY OF THE RESIDENT AND THE CAREGIVER, ON THE CONDITION THAT THE INSTRUCTIONS FOR USE ARE FOLLOWED. THE DEVICE IS EQUIPPED WITH AN EMERGENCY STOP BUTTON AND EMERGENCY LOWERING SYSTEM THAT PROVIDES SAFE AND COMFORTABLE TRANSFER COMPLETION EVEN IN CASE OF EMERGENCY SITUATION. IN SUMMARY, WHEN THE IFU AND THE CORRECT PROCEDURE OF PATIENT TRANSFER IS FOLLOWED, IT APPEARS HIGHLY UNLIKELY THAT MAXI TWIN DEVICE MAY PUT A RESIDENT AT RISK. ACCORDING TO THE AVAILABLE INFORMATION, WE MAY ASSESS THAT WHILE THE EVENT OCCURRED THE DEVICE WAS USED FOR TREATMENT OF A PERSON, AND THEREFORE IT PLAYED A ROLE IN THE EVENT. OUR EVALUATION APPEARS TO POINT OUT THAT ALLEGED RESIDENT'S FALL IS NOT LIKELY TO OCCURRE AS A CONSEQUENCE OF USING OUR DEVICE IN ACCORDANCE WITH THE SAFETY INSTRUCTION HIGHLIGHTED IN THE DEVICE INSTRUCTION FOR USE (IFU). - ATTACHMENT: [COVER LETTER.PDF].

    Description of Event or Problem · 0

    ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER USING AN ACTIVE LIFT (MAXI TWIN) AND THE SLING, THE RESIDENT FELL DOWN. NO MALFUNCTIONS REGARDING THE LIFT NOR ACCESSORIES WERE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690983 MAXI TWIN MAXI TWIN FSA ARJO HOSPITAL EQUIPMENT AB KTBB4BSX2WW

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other