BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENDALL SCDS

    MDR report key: 507204 · Received January 6, 2004

    Report

    Report Number
    MW1030762
    Event Type
    Injury
    Date Received
    January 6, 2004
    Report Date
    January 6, 2004
    Manufacturer
    KENDALL MC RAW
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAINT OR INAUDIBLE DEVICE ALARMS IN THE HOSPITAL'S CLINICAL SETTINGS COULD LEAD TO MISSED ALARMS BY THE CLINICAL PERSONNEL, AND MAY SUBJECT PTS TO PAIN AND DISCOMFORT. THESE DEVICE ALARMS ARE INHERENTLY LOW BY DESIGN AND THE ALARM VOLUMES ARE UNADJUSTABLE BY THE USERS OR THE HOSPITAL'S TECHNICAL STAFF. CLINICAL ALARMS AUDIBILITY IS ONE OF THE MAIN CHALLENGES HEALTH CARE ORGAINZATIONS ARE CURRENTLY FACING IN ORDER TO BE COMPLIANT WITH THE JCAHO'S 2003 NATIONAL PT SAFETY GOALS. ALL SCDS UNITS ARE EFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL SCDS SEQUENTIAL COMPRESSION DEVICES JOW KENDALL MC RAW 5325 *
    2 KENDALL SCDS SEQUENTIAL COMPRESSION DEVICES JOW KENDALL MC RAW 6325 *
    3 KENDALL SCDS SEQUENTIAL COMPRESSION DEVICES JOW KENDALL MC RAW 7325 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O