BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L)-PRO TRACHEAL TUBE

    MDR report key: 2971 · Received July 30, 1992

    Report

    Report Number
    2971
    Event Type
    Malfunction
    Date Received
    July 30, 1992
    Report Date
    April 6, 1992
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    INSERTED ET TUBE CUFF COULD NOT BE INFLATED. ET TUBE REMOVED AND ANOTHER INSERTED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L)-PRO TRACHEAL TUBE CUFFED ENDOTRACHEAL TUBE 7.5MM BSK MALLINCKRODT CRITICAL CARE N/A MJ04680

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other