BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESENSE

    MDR report key: 1005073 · Received February 27, 2008

    Report

    Report Number
    1650927-2008-00003
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 23, 2008
    Manufacturer
    NURSE ASSIST, INC.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SENSOR PAD FAILED TO ALERT CAREGIVER THAT RESIDENT WAS OUT OF CHAIR, WE CONDUCTED A FULL FUNCTIONAL TEST ON THE MONITOR AND PAD. THE PAD AND MONITOR WERE FULLY FUNCTIONAL. THE PAD AND MONITOR CONTINUED TO BE FULLY FUNCTIONAL AFTER THE INCIDENT.

    Description of Event or Problem · 1

    RESIDENT FELL WHILE BEING MONITORED BY A BSN-075 SENSOR PAD. PAD AND MONITOR FAILED TO SIGNAL CARE GIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESENSE CHAIR EXIT SENSOR PAD KMI NURSE ASSIST, INC. BSN-075 609024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Hospitalization