BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE (8 SIZE)

    MDR report key: 5173 · Received May 17, 1993

    Report

    Report Number
    5173
    Event Type
    Injury
    Date Received
    May 17, 1993
    Date of Event
    April 16, 1993
    Report Date
    May 4, 1993
    Manufacturer
    MALLINCKRODT
    Product Code
    LNZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ET TUBE WAS BEING VENTILATED/VENTILATOR SERVO 900C. PATIENT VOMITED WHILE INTUBATED AND ASPRIATED DUE TO FAULTY CUFF. PT'S CONDITION NOW VERY POORDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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. RESULTS OF EVALUATION: END OF LIFE - EXPECTED. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant ENDOTRACHEAL TUBE (8 SIZE) LNZ MALLINCKRODT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other