BEUDAMED
    FDA Adverse Event Injury Summary report: N

    500LB SMART LIFT NO SCALE

    MDR report key: 19939277 · Received August 8, 2024

    Report

    Report Number
    2183887-2024-00004
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 21, 2024
    Report Date
    August 5, 2024
    Manufacturer
    EZ WAY, INC
    Product Code
    FSA
    UDI-DI
    00848914000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EZ WAY TSM FINDINGS: DID TWO IN-SERVICE IS ONE AT 10:30 AND ONE AT 11 THEY'RE IN TOTAL WAS ABOUT 40 SOME PEOPLE THAT ATTENDED INCLUDING ONE OF THE PEOPLE THAT WAS THERE WHEN THE INCIDENT HAPPENED. AFTER THE IN-SERVICE WE TALK TO HER SHE WAS VERY SAD AND DID NOT HAVE A CLUE HOW THAT STRAP CAME OFF. PLAN OF ACTION IN SERVICE AND EVERY TIME THEY LIFT SOMEONE, THEY ARE GOING TO SAY TIME OUT WHEN STRAP IS TIGHT BEFORE THEY LEFT THEM IN THE AIR. BEFORE I GOT THERE, THEY COMPED OUT A LOT OF PEOPLE TO MAKE SURE THEY WERE USING THE LIFT CORRECTLY BEFORE STATE SURVEYORS GOT THERE. (B)(6) MET. WITH THE ADMINISTRATOR (B)(6) AND THE (B)(6) AND (B)(6) FIRST TO DISCUSS QUESTIONS AND TO TRY TO RE-ENACT THE INCIDENT. THEY TOLD ME PRETTY MUCH WHAT THEY TOLD (B)(6) ABOUT THE INCIDENT. THEY DID ALSO GO OVER WITH THE STATE DEPARTMENT OF HEALTH THE SITUATION AND COULD NOT FIGURE OUT HOW THIS PERSON FELL OUT OF THE LIFT. THEY DID HAVE HER HOOKED UP WITH THE STRAPS, SHOULDER SHORT, LEG, GREEN, LOWER THE BED AS FAR AS THEY COULD, AND SHE FELL OUT OF THE SLING. NOT SURE HOW THE STRAP CAME OFF. THE RESIDENT WAS MOVED OUT OF THE ICU ON (B)(6) 2024. FRACTURED STERNUM TOP OF THE BONE. HEMATOMA OF THE PELVIC REGION S37. 892 A IS THE MEDICAL CODE. (B)(6) 2024- (B)(6) SHARED THE RESIDENT WAS STILL IN THE HOSPITAL. THE PLAN IS FOR THE RESIDENT TO RETURN TO THE NURSING HOME IN 1-3 DAYS.

    Description of Event or Problem · 0

    FACILITY STATED: 2 CNAS WERE TRANSFERRING RESIDENT FROM COMMODE TO BED. THE UPPER RIGHT-HAND LOOP BY SHOULDER CAME OFF OF HANGER BAR AND RESIDENT FELL TO THE FLOOR. (B)(6) SAID THE RESIDENT WAS A VERY TOP-HEAVY PERSON. DURING THE TRANSFER, THE RESIDENT CROSSED HER HANDS AND KEPT THEM TO HERSELF. SHE WAS RIDING IN THE SLING AS DIRECTED. STAFF NOTICED A GREEN CAP CAME OFF THE HANGER BAR. THEY SAID THE GREEN CAP WAS ON THE HANGER BAR BEFORE THE TRANSFER. (B)(6) SAID THEY TRIED TO RE-ENACT THE INCIDENT, BUT THEY DON'T KNOW EXACTLY HOW IT HAPPENED. MAYBE THE RESIDENT'S BOTTOM BRUSHED THE BED OR MAYBE THE RESIDENT SHIFTED HER WEIGHT. POSSIBLY SLING WAS OFF SLIGHTLY AND WASN'T POSITIONED BEFORE MOVING THE RESIDENT. (B)(6) ALSO QUESTIONED IF THE SLING WAS POSITIONED TOO FAR UP ON RESIDENT'S BACK THE RESIDENT WAS LIFE FLIGHTED TO THE HOSPITAL. LAST KNOWN STATUS IS PATIENT WAS IN ICU. NO KNOWLEDGE OF ANY SURGERY AS OF 12:30PM ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328096 500LB SMART LIFT NO SCALE LIFT FSA EZ WAY, INC L500PN 00848914000040

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Hospitalization| L