BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMEDIATE HI-LO MODEL

    MDR report key: 4667 · Received July 31, 1992

    Report

    Report Number
    4667
    Event Type
    Malfunction
    Date Received
    July 31, 1992
    Date of Event
    January 24, 1992
    Report Date
    February 3, 1992
    Manufacturer
    MALLINCKRODT
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INTUBATED ON JANUARY 22, 1992, ET TUBE ADVANCED AND REPOSITIONED FOR NOTED AIR LEAK WITH PATIENT NOT RECEIVING FULL TIDAL VOLUMES. ON JANUARY 23, 1992, CUFF LEAK VERY EVIDENT IN RADIOLOGY WITH AIR LEAK AUDIBLE. DECREASED TIDAL VOLUME NOTED AT THAT TIME. CLINICAL ENGINEERING COULD FIND NO EVIDENCE OF AN AIR LEAKINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDIATE HI-LO MODEL BSK MALLINCKRODT

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other