BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURBELL CARESENSE BSN-020

    MDR report key: 527666 · Received May 28, 2004

    Report

    Report Number
    1650927-2004-00005
    Event Type
    Other
    Date Received
    May 28, 2004
    Date of Event
    May 8, 2004
    Report Date
    May 26, 2004
    Manufacturer
    NURSE ASSIST, INC.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED HIP FRACTURE FROM FALL THAT RESULTED WHEN CURBELL CARESENSE BED MONITOR FAILED TO SOUND. ALARM HAD SOUNDED PREVIOUSLY DURING THE SHIFT AND WAS FOUND TO BE IN THE "ON" POSITION BY 2 STAFF MEMBERS AT THE TIME OF THE INCIDENT. ALARM SUBSEQUENTLY TESTED AND FOUND TO BE IN WORKING ORDER. ALARM BATTERY HAD BEEN CHANCED WITHIN 10 DAYS PRIOR TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURBELL CARESENSE BSN-020 BED SENSOR KMI NURSE ASSIST, INC. BSN-020 212004

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization