BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESENSE BSN-020

    MDR report key: 1040164 · Received May 9, 2008

    Report

    Report Number
    1650927-2008-00004
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 8, 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 BED. WE CONDUCTED A FULL FUNCTIONAL TEST ON THE MONITOR AND PAD. THE MONITOR AND PAD WERE FULLY FUNCTIONAL. THE SENSOR PAD HAD EVIDENCE OF BEING FOLDED IN HALF. THIS KIND OF DAMAGE CAN CAUSE THE PAD TO REACT SLOWLY. THE DISTRIBUTOR WAS CAUTIONED TO INSTRUCT THE CAREGIVER ON THE PROPER CARE AND STORAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    RESIDENT FELL WHILE BEING MONITORED BY A BSN-020 SENSOR PAD. PAD AND MONITOR FAILED TO SIGNAL CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESENSE BSN-020 BED EXIT SENSOR PAD KMI NURSE ASSIST, INC. BSN-020 708042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization