BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT 600 HD LOW BASE LIFT 9153640382

    MDR report key: 7235673 · Received February 2, 2018

    Report

    Report Number
    1525712-2018-00010
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 4, 2018
    Manufacturer
    INVACARE TAYLOR ST.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO RMA ISSUED FOR RETURN DUE TO THE FACILITY STATING THE LIFT AND SLING ARE IN GOOD CONDITION AND THERE IS NO DEFECT OR MALFUNCTION. THE FACILITY HAD THE EQUIPMENT CHECKED BY THEIR MAINTENANCE AND NO ISSUES WERE FOUND WITH THE LIFT OR SLING. THE MODEL NUMBER OR MANUFACTURER OF THE SLING COULD NOT BE DETERMINED BECAUSE THE IDENTIFICATION LABELING WAS WORN OFF AND ILLEGIBLE. THE FACILITY ONLY HAS THIS ONE LIFT. IT IS USED FOR THREE RESIDENTS AT THE FACILITY AND CURRENTLY STILL IN USE. THE FACILITY DID NOT KNOW HOW LONG THEY HAVE HAD THE LIFT OR IF THERE HAS BEEN ANY PREVIOUS SERVICE ON THE IT. THERE HAVE BEEN NO ISSUES WITH THE LIFT PRIOR TO THIS EVENT. A REPRESENTATIVE OF IOWA DEPARTMENT OF INSPECTION AND APPEALS WATCHED THE FACILITY STAFF USE THE LIFT AND SLING. SHE STATED THAT THEY SEEM TO BE USING THEM PROPERLY AND HAS HAD NO FURTHER ISSUES. SHE INSPECTED THE SLING STATING THAT THE STRAPS LOOK FINE. SHE ALSO STATED THAT THE LIFT WORKS FINE AND CAN SEE NO DEFICIENCY WITH THE LIFT OR SLING. THE FACILITY HAS BEEN INSTRUCTED TO GET IN TOUCH WITH THEIR LOCAL REPRESENTATIVE TO SCHEDULE TRAINING FOR THEIR STAFF. THE FACILITY DOES HAVE THE LIFT OWNERS MANUAL ON HAND. THE LIFT MANUAL LIST MULTIPLE WARNINGS AND INSTRUCTION ON USING THE SLING INCLUDING: BE SURE TO CHECK THE SLING ATTACHMENTS EACH TIME THE SLING IS REMOVED AND REPLACED, TO ENSURE THAT IT IS PROPERLY ATTACHED BEFORE THE PATIENT IS REMOVED FROM A STATIONARY OBJECT (BED, CHAIR OR COMMODE).

    Description of Event or Problem · 1

    FACILITY STATED RESIDENT WAS IN LIFT AND THE SLING STRAP CAME OFF OF LEFT LOWER HOOK. THE STAFF ADVISED RESIDENT TILTED TO LEFT FAST AND SHE FELL TO THE FLOOR BREAKING HER HIP. THE RESIDENT WAS TAKEN TO THE HOSPITAL FOR SURGERY AND STAYED FOR ABOUT SIX DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80048 RELIANT 600 HD LOW BASE LIFT 9153640382 NON-AC POWERED PATIENT LIFT FSA INVACARE TAYLOR ST. NA:RPL600-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R