BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY CEILING LIFT GATE

    MDR report key: 3172961 · Received June 4, 2013

    Report

    Report Number
    2183887-2013-00003
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 3, 2013
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING FINAL INSPECTION OF THE INSTALLATION OF THE SYSTEM, THE INSTALLER APPLIED TOUCH-UP PAINT TO THE GATE GUIDE AND DID NOT RE-ALIGN THE GUIDE IN ITS PROPER PLACE, AS PREVIOUSLY DONE DURING THE INSTALLATION INSPECTION. EZ WAY IMPLEMENTED A MANDATORY TWO-PERSON INSTALLATION SIGN-OFF CHECKLIST PROTOCOL FOR ALL INSTALLATIONS.

    Description of Event or Problem · 1

    A CAREGIVER WAS MOVING A CEILING LIFT MOTOR ALONG THE TRACK TO POSITION THE LIFT FOR THE TRANSFER. THE MOTOR PASSED THROUGH THE GATE OF A NEWLY INSTALLED CEILING LIFT EXITING THE TRACK AND FELL ONTO A PT'S FOOT WHILE LYING ON THE BED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247551 EZ WAY CEILING LIFT GATE CEILING LIFT GATE FNG EZ WAY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA