BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMETER

    MDR report key: 4378 · Received July 20, 1992

    Report

    Report Number
    4378
    Event Type
    Injury
    Date Received
    July 20, 1992
    Date of Event
    April 28, 1992
    Report Date
    May 10, 1992
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    CCQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE INTENSIVE CARS UNIT, ON A VENTILATOR, A RESPIRATORY THERAPY STUDENT WAS PLACING AN ULTRASONIC NEBULIZER IN LINE ON THE VENTILATOR CIRCUIT. THE CONNECTORS WERE NOT MADE PROPERELY AND THE PATIENT WAS NOT VENTILATED FOR A SHORT PERIOD OF TIME. THE PATIENT BECAME APNIC, WAS RESUSCITATED WITHOUT FURTHER INCIDENT AND PLACED BACK ON THE VENTILATOR. PATIENT WAS EXTUBATED FOUR HOURS LATER, DOING WELL.VENTILATOR: BIRD 8400 ST; MODEL #15020; SERIAL #KA001707; CONTROL #16-0319DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMETER ULTRASONIC NEBULIZER CCQ ALLIED HEALTH CARE PRODUCTS, INC. MP500

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention