BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMETER

    MDR report key: 571034 · Received February 14, 2005

    Report

    Report Number
    571034
    Event Type
    Malfunction
    Date Received
    February 14, 2005
    Date of Event
    October 31, 2004
    Report Date
    November 30, 2004
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS INC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIALYSIS PATIENT COMPLAINED OF NOT FEELING WELL. AT END OF TREATMENT PATIENT BEGAN HAVING SEIZURE ACTIVITY. STAFF TRIED TO SUCTION PATIENT USING TWIN-O-VAC BUT WAS UNABLE TO GET IT TO FUNCTION. AFTER INCIDENT RT, RESPIRATORY THERAPIST CHECKED TWIN-O-VAC. UNIT AS AN O2 FLOW METER ATTACHED. KNOB ON FLOW METER WAS FOUND TO BE LOOSE AND DID NOT ALLOW O2 TO ENTER. THE KNOB IS HELD IN PLACE BY AN ALLEN SCREW WHICH HAD LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMETER FLOWMETER CAN ALLIED HEALTH CARE PRODUCTS INC TLO-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other