BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 18243020 · Received November 30, 2023

    Report

    Report Number
    3008406502-2023-00005
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 30, 2023
    Manufacturer
    TOLLOS, INC.
    Product Code
    FSA
    UDI-DI
    00817956020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TOLLOS DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE FAILURE MODE, BUT BASED UPON AGE, IT IS BELIEVED THAT THE MOST LIKELY CAUSE IS SIMPLY WEAKENING WITH YEARS OF WEAR AND TEAR. THIS CONCLUSION IS BASED MOSTLY ON THE RARITY OF AN ACTUATOR FAILURE. TOLLOS HAS NEVER RECEIVED A REPORT OF A LINAK ACTUATOR FAILURE IN THE YEARS THAT THEY HAVE BEEN USED.

    Description of Event or Problem · 0

    THE CUSTOMER/FACILITY REPORTED THAT THE LIFTING ACTUATOR (LINAK) ON AN ULTRALIFT BROKE WHILE LIFTING A PATIENT. THE PATIENT WAS NOT INJURED. OF NOTE IS THAT THE LIFT DOM WAS (B)(6) 2012 AND THE ACTUATOR IS ORIGINAL TO THE LIFT. PLEASE NOTE THAT THE FACILITY WOULD NOT PROVIDE ANY PATIENT RELATED DATA, SO THE INFORMATION LISTED IS ONLY A PLACEHOLDER SO THAT THIS REPORT COULD BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538955 TOLLOS MOBILE LIFT FSA TOLLOS, INC. ULTRALIFT 600 00817956020026

    Patients

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