BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SIX STRAP SLING

    MDR report key: 2942194 · Received January 30, 2013

    Report

    Report Number
    2942194
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 30, 2013
    Manufacturer
    TOLLOS, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    THE CNA REPORTED THE HANDLE ON BACK OF THE CEILING LIFT TORE AS SHE AND A PT TECH WERE GUIDING THE PATIENT INTO HIS CUSTOMIZED WHEELCHAIR. SHE STATED THEY TRIED TO AVOID PULLING ON THE HANDLES, BUT POSITIONING THIS PATIENT IS DIFFICULT BECAUSE HE NEEDS TO BE SEATED BETWEEN DEVICES IN THE CHAIR THAT PREVENT HIM FROM LEANING TO THE SIDE.THE TEAR WAS AT ONE HANDLE IN THE BACK OF THE SLING, NOT AT A HANDLE THAT ATTACHES TO THE CEILING LIFT. THE STAFF INVOLVED WERE AWARE THAT THE COMPANY ADVISED NOT PULLING ON THESE HANDLES. (RE-EDUCATION WAS PROVIDED LAST WEEK). THE COMPANY REP ALSO REPORTED THAT A RE-DESIGN OF THESE HANDLES IS BEING CONSIDERED.THE CEILING LIFT SLING IS A LARGE COMBI SLING, LOT NUMBER 1631210BD SN: (B)(4). PT WT (B)(6) KG. IT HAS BEEN REMOVED FROM SERVICE AND IS CURRENTLY IN THE NURSE MANAGER'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40995 COMBI SIX STRAP SLING PATIENT LIFT, SLING, CEILING FNG TOLLOS, INC. * 163120BD

    Patients

    Seq Age Sex Outcome Treatment
    1 *