BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART ALARM

    MDR report key: 2655835 · Received January 30, 2009

    Report

    Report Number
    2655835
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    January 21, 2009
    Report Date
    January 30, 2009
    Manufacturer
    SMART CAREGIVER CORP
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT'S BED ALARM WAS NOTED TO BE ATTACHED TO THE BED, BUT NOT SOUNDING WHEN THE RESIDENT WAS FOUND ON THE FLOOR. RESIDENT SUSTAINED A FACIAL FX AND A LEFT HIP FX. THIS WAS A BRAND NEW ALARM PURCHASED IN (B)(6) 2008, THAT WAS JUST PUT IN TO SERVICE (B)(6) WEEKS PRIOR TO THIS EVENT. THE BATTERIES WERE BRAND NEW AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART ALARM BED ALARM KMI SMART CAREGIVER CORP TL-2100CP

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization