BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEILING LIFT SLING

    MDR report key: 8103064 · Received November 26, 2018

    Report

    Report Number
    8103064
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 11, 2018
    Report Date
    November 15, 2018
    Manufacturer
    HANDICARE USA, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SLING WAS ATTACHED TO THE OVERHEAD CEILING LIFT IN PREPARATION FOR PATIENT TRANSFER TO THE CHAIR WHEN THE STAFF NOTICED MULTIPLE RIPS IN THE SLING. THIS WAS IDENTIFIED AS HAVING OCCURRED ON TWO OTHER PATIENTS. TWO OF THE SLINGS WERE DISPOSED OF. THE THIRD WAS SEQUESTERED. UPON INSPECTION, THE BLUE NETTING WAS SEPARATING AROUND THE PERIMETER OF THE SLING, CLOSE TO THE YELLOW BINDING. THERE WAS NO EVIDENCE OF THE MATERIAL HAVING BEEN CUT. THE MANUFACTURER'S REP WAS NOTIFIED. THERE WAS NO PATIENT HARM WITH ANY OF THE INCIDENTS. MANUFACTURER RESPONSE FOR CEILING LIFT SLING, CEILING LIFT (PER SITE REPORTER). THE MANUFACTURER HAS NOTIFIED THEIR QUALITY GROUP IN (B)(6). THEY ARE ALSO WORKING WITH US TO REPLACE THE SLINGS IN QUESTION.

    Description of Event or Problem · 1

    THE SLING WAS ATTACHED TO THE OVERHEAD CEILING LIFT IN PREPARATION FOR PATIENT TRANSFER TO THE CHAIR WHEN THE STAFF NOTICED MULTIPLE RIPS IN THE SLING. THIS WAS IDENTIFIED AS HAVING OCCURRED ON TWO OTHER PATIENTS. TWO OF THE SLINGS WERE DISPOSED OF. THE THIRD WAS SEQUESTERED. UPON INSPECTION, THE BLUE NETTING WAS SEPARATING AROUND THE PERIMETER OF THE SLING, CLOSE TO THE YELLOW BINDING. THERE WAS NO EVIDENCE OF THE MATERIAL HAVING BEEN CUT. THE MANUFACTURER'S REP WAS NOTIFIED. THERE WAS NO PATIENT HARM WITH ANY OF THE INCIDENTS. MANUFACTURER RESPONSE FOR CEILING LIFT SLING, CEILING LIFT (PER SITE REPORTER). THE MANUFACTURER HAS NOTIFIED THEIR QUALITY GROUP IN (B)(6). THEY ARE ALSO WORKING WITH US TO REPLACE THE SLINGS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942049 CEILING LIFT SLING LIFT, PATIENT, NON-AC-POWERED FSA HANDICARE USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1