BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST

    MDR report key: 2805603 · Received November 15, 2010

    Report

    Report Number
    2805603
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 9, 2010
    Manufacturer
    NURSE ASSIST, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED ON (B)(6) 2010, TO A SWING BED FOLLOWING CEMENTED LEFT HEMI-ARTHROPLASTY. PT WAS ON FALL PRECAUTIONS AND NURSE ASSIST. FALL ALARM AT THE NURSE'S STATION AT 12:25 PM, (B)(6) 2010, AS IT HAD EARLIER THAT DAY AND SINCE THE PT WAS ADMITTED ON (B)(6) 2010. THE PT WAS FOUND IN THE FLOOR AT 12:25 PM ON (B)(6) 2010, UNABLE TO GET UP. THE GREEN LIGHT INDICATING BATTERY STATUS AND UNIT FUNCTION WAS ILLUMINATED, INDICATING THAT THE NURSE ASSIST FALL ALARM WAS PROPERLY WORKING. UPON INVESTIGATION BY THE NURSE ON DUTY, IT WAS FOUND THAT THE PORT FOR THE COMMUNICATION CABLE WAS BROKEN; THUS, PREVENTING THE CORD FROM REMAINING IN PLACE. THE PT WAS CRACKED AND CHIPPED WITH A PIECE OF THE PLASTIC EDGE THAT HELD THE CORD IN PLACE WITHIN THE PORT WAS MISSING. THE ROOM WAS SEARCHED AND THE PLASTIC THAT WAS CHIPPED OFF WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NURSE ASSIST FALL ALARM KMI NURSE ASSIST, INC 15-100

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention