BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODE ALERT - SENSATEC

    MDR report key: 206068 · Received January 12, 1999

    Report

    Report Number
    MW1015445
    Event Type
    Malfunction
    Date Received
    January 12, 1999
    Date of Event
    January 2, 1999
    Report Date
    January 5, 1999
    Manufacturer
    R F TECHNOLOGY, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHAIR ALARM DID NOT SOUND. WHEN PRESSURE RELIEVED FROM ALARM, IT DOES NOT RING. PRESIDENT FELL WITHOUT INJURY. SENSOR PAD FAULTY, AS WHEN NEW PAD PLACED ON ALARM, THE ALARM ITSELF WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT - SENSATEC DISPOSABLE CHAIR SENSOR PAD KMI R F TECHNOLOGY, INC. ST 220 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR