BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANDERLIFT 450

    MDR report key: 2061313 · Received April 5, 2011

    Report

    Report Number
    1933441-2011-00004
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 23, 2011
    Manufacturer
    VANCARE, INC.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR WENT TO THE FACILITY ON (B)(6) 2011 TO INVESTIGATE INCIDENT. HE TOOK PICTURES OF THE LIFT OF WHICH ONE IS INCLUDED IN THIS REPORT. NO PICTURES OF THE SLINGS THAT WERE USED WERE TAKEN AS THEY STATED THEY WERE IN SERVICE WHILE HE WAS THERE. IT WAS DETERMINED THAT THE SCALE AND THE ATTACHMENT ARE NOT VANCARE PRODUCTS. THE OVAL CLIP ATTACHED TO THE ARM OF THE LIFT AND ATTACHED TO THE SCALE ALLOWS FOR EXCESSIVE MOVEMENT OF THE HANGER BAR ASSEMBLY. AGAIN ONLY VANCARE SLINGS ARE TO BE USED ON VANDERLIFTS. FACILITY WAS DIRECTED BY THE DISTRIBUTOR TO TAKE THE LIFT OUT OF SERVICE UNTIL IT COULD BE FITTED WITH VANCARE APPROVED SCALE AND HANGER ATTACHMENT HARDWARE.

    Description of Event or Problem · 1

    TRANSFER FROM BED TO CHAIR WITH ONE EXPERIENCED STAFF MEMBER AND ONE INEXPERIENCED STAFF MEMBER. THIS INCIDENT WAS NOT REPORTED TO US UNTIL (B)(6) 2011. DURING THIS TRANSFER, THEY USED AN ALIMED UNIVERSAL SLING #(B)(4) WHICH IS NOT TO BE USED WITH A VANDERLIFT WAS OUTLINED AND STATED IN ALL MATERIALS AND TRAINING PRODUCTS. ONLY VANCARE SLINGS ARE TO BE USED WITH VANCARE LIFTS. STAFF MEMBERS STATED THIS HAPPENED QUICKLY AND THEY DON'T KNOW EXACTLY WHAT HAPPENED. FACILITY DID AN INTERNAL INVESTIGATION AND DETERMINED THIS INCIDENT WAS DUE TO USER INEXPERIENCE. RESIDENT WAS RELEASED BACK TO THE FACILITY THE SAME DAY AS THE INJURY. PATIENT PASSED AWAY 24 HOURS LATER, AND WAS DETERMINED BY FACILITY TO BE NON RELATIVE TO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANDERLIFT 450 VANDERLIFT FSA VANCARE, INC. 450

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization