BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDCARE LIFT AND UNKNOWN SLING

    MDR report key: 843000 · Received April 20, 2007

    Report

    Report Number
    2135150-2007-00003
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    February 17, 2007
    Report Date
    February 28, 2007
    Manufacturer
    MEDCARE PRODUCTS
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR INTERVIEWS OF FACILITY STAFF, IT APPEARS THAT THE FACILITY WAS USING A NON-MEDCARE SLING. THEY STATED SOME CONFUSION WHEN REVIEWING OUR OPERATIONS MANUAL, BECAUSE THE SLING INVOLVED IN THIS INCIDENT HAD DIFFERENT COLOR LOOPS THAN THOSE IN OUR OPERATION MANUAL. THE COLOR LOOPS ON THE SLING THEY USED ARE A GOOD INDICATOR THAT THEY WERE USING ANOTHER MANUFACTURER'S SLING IN COMBINATION WITH OUR LIFT. THIS IS A VIOLATION OF OUR POLICY THAT ONLY OUR SLINGS SHOULD BE USED WITH OUR LIFTS AS WE HAVE NOT TESTED THE COMPATIBILITY OF OTHER MANUFACTURER'S SLINGS WITH OUR LIFTS. THERE WAS NO MALFUNCTION OF THE LIFT. HOWEVER, THIS LIFT WAS NOT MANUFACTURED BY MEDCARE PRODUCTS, INC. IT WAS MANUFACTURED BY MEDCARE PRODUCTS LLC. THIS IS A NON-RELATED COMPANY THAT WE PURCHASED THE ASSETS FROM IN 1998. IT SHOULD BE NOTED THAT THIS FACILITY HAD ANOTHER, NON-RELATED INCIDENT ON 02/09/07. SEE MANUFACTURER REPORT NUMBER 2135150-2007-00002. FOLLOWING THIS INCIDENT, WE SCHEDULED AN INSERVICE APPOINTMENT FOR OUR REPRESENTATIVE TO VISIT THE FACILITY TO CONDUCT AN INSERVICE OF STAFF. THE FACILITY CANCELLED THIS INSERVICE. THE INSERVICE HAS BEEN RESCHEDULED FOR 3/5/07. THE LIFT AND SLING INVOLVED IN THIS INCIDENT HAVE BEEN TAKEN OUT OF SERVICE PENDING AN INVESTIGATION BY OUR REPRESENTATIVE.

    Description of Event or Problem · 1

    DURING A TRANSFER FROM A BED TO A CHAIR USING A PATIENT LIFT AND SLING, THE TOP TWO LOOPS OF THE SLING SLIPPED OFF THE HANGER BAR. THE PATIENT FELL TO THE FLOOR AND HIT THEIR HEAD ON THE LIFT LEG. THE PATIENT SUSTAINED A LACERATION ON THE BACK OF THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE LIFT AND UNKNOWN SLING PATIENT LIFT AND PATIENT SLING FNG MEDCARE PRODUCTS 400001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization