BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXISKY 600

    MDR report key: 2163460 · Received June 17, 2011

    Report

    Report Number
    9681684-2011-00045
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH TECHNICIAN AFTER THE INCIDENT. HE PERFORMED A FULL FUNCTION TEST ON THE UNIT AND ALSO CHECKED FOR ANYTHING WRONG. THE UNIT WAS IN PERFECT WORKING CONDITION AND IT WAS SAID NOTHING HAD BEEN TOUCHED. WHILE SHE WAS INTERVIEWED BY THE FACILITY DIRECTOR, THE PRIVATE CARE ATTENDANT INVOLVED IN THE INCIDENT COULD NOT RECALL ATTACHING THE LEG STRAP ON HER SIDE (RIGHT) OF THE RESIDENT. MOREOVER, THE ARJOHUNTLEIGH TECHNICIAN RECREATED THE EVENT BY ACTING AS THE RESIDENT AND, WHEN CONNECTING FIVE OF THE SIX STRAPS, LEAVING OFF THE RIGHT LEG STRAP, HE FELL IN THE EXACT POSITION THAT THE RESIDENT HAD FALLEN. SINCE NO MALFUNCTION OF THE SLING WAS REPORTED, THE MANUFACTURER DID NOT CONSIDER THAT THE SLING COULD HAVE BEEN A CONTRIBUTING FACTOR OF THE INCIDENT. IT IS ALSO CONSIDERED THAT THE SLING MODEL AND SIZE WERE APPROPRIATE FOR THE RESIDENT. SOME POSSIBLE SCENARIOS WERE BROUGHT FORWARD DURING INTERNAL SIMULATIONS TO EXPLAIN HOW A RESIDENT CAN SLIDE OUT OF A QUICK-FIT SLING. THE POSSIBILITIES FOUND PLAUSIBLE ALL SET FORTH A SCENARIO WHERE A STRAP HAS BEEN INCORRECTLY INSTALLED AT THE BEGINNING OF THE TRANSFER. IN THE PRESENT CASE, SINCE THE PRIVATE CARE ATTENDANT MENTIONED SHE COULD NOT RECALL ATTACHING THE LEG STRAP ON HER SIDE OF RESIDENT (RIGHT), IT APPEARS TO BE THE MOST PLAUSIBLE CAUSE OF THE FALL. THE INTERNAL SIMULATION ALSO SHOWED THAT, WHEN ONE OF THE LEG STRAPS IS NOT ATTACHED, THE RISK OF FALL WOULD INCREASE IF THE RESIDENT HAS A LOW MUSCULAR TONUS, ESPECIALLY TO THE ABDOMINAL, BUTTOCK AND DORSAL MUSCLES, WHICH AGREE WITH THE TYPE OF RESIDENT INVOLVED IN THIS INCIDENT. SINCE THE MAXI SKY 600 INSTRUCTIONS FOR USE CLEARLY WARNS TO INSPECT ALL STRAP ATTACHMENTS BEFORE LIFTING A PATIENT, IT SEEMS THAT THE PRIVATE CARE ATTENDANT DID NOT ADHERE TO THE RECOMMENDATIONS OF THE INSTRUCTIONS FOR USE BY PERFORMING A VISUAL INSPECTION BEFORE INITIATING THE TRANSFER. IT MUST ALSO BE NOTED THAT NO FORMAL TRAINING WAS EVER GIVEN TO HER. IT IS STRONGLY RECOMMENDED TO THE CUSTOMER TO RETRAIN THE PERSONNEL THAT UTILIZE THE DEVICE AND RECORD THIS RETRAINING.

    Description of Event or Problem · 1

    DURING A RESIDENT TRANSFER FROM BED TO WHEEL CHAIR BY TWO STAFF MEMBERS, A RESIDENT SLIPPED OUT OF THE SLING WHILE SHE WAS LIFTED UP AND MOVED TOWARDS THE CHAIR. THE RESIDENT WAS BROUGHT TO THE EMERGENCY ROOM WHEN A FRACTURE TO THE RIGHT CLAVICLE WAS DIAGNOSED, AS WELL AS LACERATIONS AND CONTUSIONS TO THE RIGHT OCCIPITAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FNG BHM MEDICAL, INC. LD10211

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O