BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATEC

    MDR report key: 562632 · Received December 29, 2004

    Report

    Report Number
    2134311-2004-00001
    Event Type
    Injury
    Date Received
    December 29, 2004
    Date of Event
    November 24, 2004
    Report Date
    December 23, 2004
    Manufacturer
    R.F. TECHNOLOGIES, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING CONTROLLER WITH A BED PAD. WHEN PT TRIED TO GET UP, PT FELL. THE REPORT ALLEGED THAT THE ALARM DID NOT SOUND. REPORT ALSO INDICATED THAT THE PT BROKE THEIR HIP. COMPLAINANT BELIEVED THAT THE PAD WAS IN USE BEYOND THE LABELED 30-DAY USE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATEC BED-CHAIR MONITOR KMI R.F. TECHNOLOGIES, INC. ST-260 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization