BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 14719915 · Received June 16, 2022

    Report

    Report Number
    3008406502-2022-00004
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 16, 2022
    Manufacturer
    TOLLOS, INC
    Product Code
    FSA
    UDI-DI
    00817956021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TENSILE STRENGTH TEST: A LOGICAL HYPOTHESIS WITH A BROKEN BELT IS THAT THE MATERIAL IS NOT STRONG ENOUGH FOR ITS USE, OR THAT A DEFECT WAS PRESENT AT MANUFACTURE. IN ORDER TO TEST THIS HYPOTHESIS, TOLLOS SENT SAMPLES OF NEW BELTS, AS WELL AS BELTS REMOVED FROM A CUSTOMER'S LIFTS (THAT WERE USED FOR THREE YEARS) TO THE MANUFACTURER OF THE BELTS, BRECOFLEX, AND TO AN INDEPENDENT THIRD-PARTY LAB, NTS, LOCATED IN FULLERTON, CA. THE INTENT OF THIS TESTING IS TO PROVIDE DATA ON THE FOLLOWING: TENSILE STRENGTH OF NEW BELTS, TENSILE STRENGTH OF BELTS USED FOR APPROXIMATELY 3 YEARS, DATA TO DETERMINE IF DEGRADATION OF THE TENSILE STRENGTH OCCURS OVER TIME AND WITH USE. RESULTS: EACH LAB USED A DIFFERENT METHOD, WHICH PRODUCED RESULTS AS FOLLOWS: NTS, NTS CONNECTED THE BELT TO THE TESTING EQUIPMENT BY PLACING A PIN THROUGH EACH LOOPED END OF THE BELT AND DID A PULL ON THE FULL EIGHT-FOOT LENGTH. THE FAILURE POINT WAS THE SAME ON ALL (NEW AND USED) BELTS. THE WEAKEST POINT IS THE SEWN END THAT CONNECTS TO THE SPOOL. THIS END WOULD RARELY, IF EVER, BE UNDER LOAD BECAUSE THE USER WOULD NEED TO LOWER THE LOAD TO THE MAXIMUM EXTENT. THIS WOULD GENERALLY PLACE THE LOAD ON THE FLOOR SO AS NOT TO BE SUPPORTED BY THE BELT. EVEN IF IT IS POSSIBLE TO UNSPOOL THE BELT ENTIRELY SO THAT THE LOAD IS SUPPORTED BY THE SEWN END, THE TENSILE STRENGTH IS APPROXIMATELY 1500 LBS, WELL ABOVE THE LOAD RATING OF THE LIFT. BRECOFLEX: BRECOFLEX CUT THE BELTS INTO SEGMENTS TO TEST THE STRENGTH AT THE LOOPED END, THE MIDDLE, AND THE SEWN END. BRECOFLEX CLAMPED EACH END INTO THEIR TEST EQUIPMENT IN ORDER TO APPLY TENSION TO THE BELT. THE WEAKEST POINT WAS CONSISTENT WITH THE NTS TEST RESULTS. THE BREAKING POINT OF THE SEWN END WAS APPROXIMATELY 2000 POUNDS. AS NOTED, THIS END WILL RARELY, IF EVER, HAVE THIS FORCE APPLIED BECAUSE THE LOAD WOULD BE LOWERED TO THE GROUND FIRST. THE MIDDLE AND LOOPED END (SPREADER BAR END) HAS A BREAKING POINT OF APPROXIMATELY 3000 LBS. CONCLUSION: THE FULL TEST REPORTS ARE INCLUDED FOR REVIEW. THE EXACT FAILURE FORCE VARIES TO A SMALL DEGREE FROM ONE BELT TO THE NEXT. A CONSISTENT CONCLUSION WAS THAT THE SEWN END IS THE WEAKEST PORTION OF THE BELT, BUT EVEN AT ITS WEAKEST POINT, ALL THE BELTS, NEW AND USED, WERE CAPABLE OF LIFTING MORE THAN 1.5X THE LOAD RATING OF THE LIFT (750 LBS.). THE USED BELTS WERE COMPARABLE IN STRENGTH TO THE NEW BELTS, SO IT DOES NOT APPEAR THAT DEGRADATION FROM USE (IN THE ABSENCE OF DAMAGE) OR AGE IS A SIGNIFICANT PROBLEM. INHERENT WEAKNESS, OR DEFECT OF THE BELT DOES NOT APPEAR TO BE A FAILURE MODE. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    FROM THE USER MEDWATCH 3500 FORM (THIS INFORMATION WAS NOT PROVIDED DIRECTLY TO THE MANUFACTURER); THE PATIENT WAS BEING TRANSFERRED FROM THE BED TO THE BEDSIDE COMMODE IN A COMBI SLING WITH THE USE OF THE CEILING LIFT. THE CEILING LIFT STRAP BROKE, AND THE PATIENT FELL APPROXIMATELY 3FT, LANDING DIRECTLY ON THE BEDSIDE COMMODE. THE BAR ATTACHED TO THE LIFT DID FALL ON THE RN AND CNA, WHO BOTH WERE REFERRED TO THE ED FOR EVALUATION. FROM MANUFACTURER: PLEASE NOTE THAT THE FACILITY DID NOT PROVIDE THE MANUFACTURER WITH ANY INFORMATION RELATED TO THE PATIENT. THE BIRTHDATE AND AGE ARE JUST PLACEHOLDERS TO ALLOW SUBMISSION OF THIS MDR, THE ACTUAL BIRTHDATE AND AGE ARE UNKNOWN TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958246 TOLLOS PATIENT LIFT (CEILING LIFT) FSA TOLLOS, INC CIRRUS 750 00817956021

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Prefer Not To Disclose