BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CAREGIVER ALERT

    MDR report key: 500658 · Received December 10, 2003

    Report

    Report Number
    500658
    Event Type
    Injury
    Date Received
    December 10, 2003
    Date of Event
    November 26, 2003
    Report Date
    December 9, 2003
    Manufacturer
    SMART CAREGIVERS CORP.
    Product Code
    KMI
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT ON FLOOR IN SITING POSITION, ALARM SOUNDED ON BED; STARTED SOUNDING AFTER STAFF ENTERED ROOM. BED ALARM WAS ON, BUT DID NOT SOUND OFF UNTIL AFTER RESIDENT WAS ALREADY ON FLOOR. RESIDENT SENT TO HOSPITAL WITH A FX TO LEFT HIP. HAD ORIF IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CAREGIVER ALERT RESTRAINT FREE ALARM W/PAD KMI SMART CAREGIVERS CORP. SMART CAREGIVER ALERT *

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| O