BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ WAY, INC.

    MDR report key: 6607424 · Received June 2, 2017

    Report

    Report Number
    2183887-2017-00001
    Event Type
    Death
    Date Received
    June 2, 2017
    Date of Event
    April 23, 2017
    Report Date
    June 1, 2017
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONLY PLAUSIBLE CAUSE THAT THE NURSE AIDE (DEVICE OPERATOR) COULD COME UP WITH, IS THAT SHE HAD NOT PROPERLY PLACE THE LOOP OF THE SLING PAST THE SAFETY CLIP ON THE STAND. THE CONCLUSION REACHED BY THE NURSE AIDE IS THE ONLY EXPLAINABLE ANSWER TO HOW IT HAPPENED, AS BOTH THE LIFT AND THE SLING CHECKED OUT IN GOOD WORKING ORDER BY THE PEOPLE AT (B)(6) CARE CENTER, (B)(6) OF THE (B)(6) DEPARTMENT OF AGING AND DISABILITY'S, AND (B)(6) OF EZ WAY, INC.

    Description of Event or Problem · 1

    ON 05/05/2017 (B)(6) OF OUR SERVICE DEPARTMENT RECEIVED A CALL FROM (B)(6), A NURSE SURVEYOR OF REGULATORY WITH THE (B)(6) DEPARTMENT OF AGING AND DISABILITIES SERVICES. (B)(6) WAS ASKING FOR THE PROOF OF A PART PURCHASE. (B)(6) TOLD (B)(6) THERE WAS AN ACCIDENT THAT HAD OCCURRED RESULTING IN A DEATH AT THE (B)(6) CARE CENTER AND WAS FOLLOWING UP TO SEE THAT THE FACILITY HAD BOUGHT NEW SAFETY CLIPS. (B)(6) INFORMED (B)(6) THAT THE FACILITY HAD MADE THEIR OWN YELLOW SAFETY CLIPS. AFTER RECEIVING THE CALL FROM (B)(6), (B)(6) CONTACTED (B)(6) AT (B)(6) CARE FACILITY TO FIND OUT MORE INFORMATION. IN AN EMAIL FROM (B)(6) 05/05/2017 AT 2:17 PM; (B)(6) DESCRIPTION IN HER OWN WORDS IS AS FOLLOWS: "NURSE AIDE HAD RESIDENT RAISED IN LIFT. RIGHT CANVAS HOOK CAME LOOSE FROM PIGTAIL HOOK. IN RE-ENACTMENT, NURSE AIDE DECIDED SHE MUST HAVE NOT HOOKED IT OVER THE CLIP, BUT RATHER ON TOP OF THE CLIP. THAT IS THE ONLY WAY IT COULD HAVE SLIPPED OFF WHILE IT HAD THE RESIDENT'S FULL WEIGHT. LIFT AND CANVAS HARNESS WERE FULLY EVALUATED AFTERWARD AND SHOW NO MECHANICAL OR WEAR/TEAR SIGNS. WHEN CANVAS HOOK CAME LOOSE, RESIDENT FELL AND HIT HEAD ON DOOR IMMEDIATELY BEHIND HIM. RESIDENT WAS PRONOUNCED A FEW MINUTES LATER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389329 EZ WAY, INC. EZ STAND PREMIER 400 LB FSA EZ WAY, INC. 896

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death