BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANDERLIFT 450

    MDR report key: 2061304 · Received April 5, 2011

    Report

    Report Number
    1933441-2011-00005
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 25, 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 THIS INCIDENT. HE TOOK PICTURES OF THE LIFT OF WHICH ONE IS INCLUDE IN THIS REPORT. PICTURES OF THE SLING USED WAS NOT TAKEN AS FACILITY STATED THEY WERE IN USE. 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. FACILITY WAS DIRECTED BY THE DISTRIBUTOR TO TAKE THE LIFT OUT OF SVC UNTIL IT COULD BE FITTED WITH VANCARE APPROVED SCALE AND HANGER ATTACHMENT HARDWARE. THIS IS THE SAME LIFT THAT WAS USED IN ANOTHER INCIDENT AT THIS FACILITY THAT HAS PREVIOUSLY BEEN REPORTED. INJURIES: THE RESIDENT SUFFERED A 4CM LACERATION TO THE HEAD REQUIRING 2 STAPLES, AND A HEMATOMA OF THE HEAD. CT OF THE HEAD, AND C-SPINE WERE BOTH NEGATIVE. THE RESIDENT WAS NOT ADMITTED TO THE HOSPITAL, AND RETURNED TO THE FACILITY THE SAME DAY. WHAT HAPPENED: BED TO CHAIR TRANSFER. ACCORDING TO (B)(6), THE RESIDENT SHIFTED THEIR WEIGHT WHILE RAISED WHICH CAUSED THE LEFT SIDE HEAD STRAP TO FALL OFF THE HANGER BAR. (B)(6) DID NOT SPECIFY WHAT AN INTERNAL INVESTIGATION FOUND REGARDING THIS INCIDENT.

    Description of Event or Problem · 1

    DURING TRANSFER FROM A BED TO THE CHAIR, PT FELL OUT OF SLING. SLING BEING USED WAS A ALIMED UNIVERSAL SLING ITEM #(B)(4), WHICH ARE NOT TO BE USED WITH A VANDERLIFT AS IS OUTLINED AND STATED IN ALL MATERIAL AND TRAINING PRODUCTS. ONLY VANCARE SLINGS ARE TO BE USED WITH VANCARE LIFTS. (B)(6) WAS UNSURE OF WHAT SIZE WAS USED DURING TRANSFER. (B)(6) DID NOT SPECIFY WHAT THE INTERNAL INVESTIGATION FOUND REGARDING THIS 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 79 YR Hospitalization