BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO TRACHEAL TUBE

    MDR report key: 6710 · Received October 4, 1993

    Report

    Report Number
    6710
    Event Type
    Malfunction
    Date Received
    October 4, 1993
    Date of Event
    September 22, 1993
    Report Date
    October 4, 1993
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CUFF HAD TO BE INFLATED THREE TIMES BEFORE SEALED.DEVICE 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: A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LO-PRO TRACHEAL TUBE BTR MALLINCKRODT CRITICAL CARE MW06590

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other