BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS CIRRUS 750

    MDR report key: 18213382 · Received November 27, 2023

    Report

    Report Number
    3008406502-2023-00004
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    September 16, 2023
    Report Date
    November 27, 2023
    Manufacturer
    1073849 ONTARIO LTD., DBA TOLLOS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF THE DEFECT, MALFUNCTION OR ERROR IN USE OF THE DEVICE: CUSTOMER REPORTED TO THE FDA THROUGH THE MEDWATCH PROGRAM AS FOLLOWS: AS PATIENT WAS BEING LIFTED OFF OF THE BED USING THE HOYER LIFT IN THE CEILING, THE LIFT FELL OUT OF THE CEILING AND ONTO THE PATIENT'S ABDOMEN. WE BELIEVE THAT THERE WERE TWO PINS MISSING THAT HOLD IT TO THE MOUNT. NO INJURY TO THE PATIENT. · ROOT CAUSE OF THE PROBLEM (IF KNOWN): THE FACILITY WOULD NOT SHARE ANY INFORMATION OTHER THAN TO COMMENT THAT THEY DETERMINED THAT THE EVENT WAS CAUSED BY AN INSTALLATION FAILURE. BASED ON THE DESCRIPTION OF THE EVENT (TWO PINS MISSING) TOLLOS BELIEVES THAT THE LIFT WAS TAKEN DOWN BY DISCONNECTING THE TROLLEY AND WHEN REINSTALLED, THE PINS WERE NOT PUT IN. THIS WOULD NOT BE AN EQUIPMENT FAILURE. ROOT CAUSE MAY BE RELATED TO EMPLOYEE EDUCATION, BUT SINCE TOLLOS HAS NOT BEEN GIVEN ANY ADDITIONAL INFORMATION, THE RC CANNOT BE DETERMINED.. · FACTORS THAT MAY CONTRIBUTE TO PRODUCT RISK (I.E. DEVICE DESIGN, MANUFACTURING PROBLEMS OR USER ERROR): THIS EVENT SEEMS TO HAVE BEEN CAUSED BY ERROR ON THE PART OF A SERVICE TECHNICIAN; HOWEVER, THIS CANNOT BE DETERMINED WITH CERTAINTY BECAUSE THE FACILITY WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING DESCRIPTION WAS TAKEN FROM THE FACILITY'S MEDWATCH REPORT (MW5146867): AS PATIENT WAS BEING LIFTED OFF OF THE BED USING THE HOYER LIFT IN THE CEILING, THE LIFT FELL OUT OF THE CEILING AND ONTO THE PATIENT'S ABDOMEN. WE BELIEVE THAT THERE WERE TWO PINS MISSING THAT HOLD IT TO THE MOUNT. NO INJURY TO THE PATIENT. THE MANUFACTURER (TOLLOS) REACHED OUT TO THE FACILITY FOR MORE INFORMATION. THE FACILITY PROVIDED THE SERIAL NUMBER AND ONLY SAID THAT THEY (THE FACILITY) DETERMINED THAT THE EVENT OCCURED BECAUSE OF AN INSTALLATION PROBLEM. IN REVIEWING THE STATEMENTS, THE MANUFACTURER BELEIVES THAT MOST LIKELY, THE LIFT WAS TAKEN DOWN FROM THE TROLLEY FOR SERVICE (OR SOME OTHER REASON) AND WHEN IT WAS REPLACED, THE TWOM PINS WERE NOT REINSTALLED (SAFETY AND SUPPORT PINS). PLEASE NOTE THAT THE FACILITY WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION AND THAT THE CAUSE OF THE EVENT MAY CHANGE IF FURTHER INFORMATION IS PROVIDED. THE FACILITY DID NOT PROVIDE ANY INFORMATION ABOUT THE PATIENT, SO THE MANUFACTURER USED PALCEHOLDER VALUES FOR AGE AND WEIGHT IN ORDER TO SUBMIT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523555 TOLLOS CIRRUS 750 CEILING LIFT - PATIENT LIFT FSA 1073849 ONTARIO LTD., DBA TOLLOS, INC. CIRRUS 750

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Prefer Not To Disclose