BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-LO- TRACHEAL TUBE CUFFED, MURPHY EYE

    MDR report key: 129 · Received December 31, 1991

    Report

    Report Number
    129
    Event Type
    Death
    Date Received
    December 31, 1991
    Date of Event
    December 7, 1991
    Report Date
    December 18, 1991
    Manufacturer
    MALLINCKRODT
    Product Code
    BSK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH MYASTHENIA GRAVIS DEVELOPED RESPIRATORY ARREST. THE PHYSICIAN INTUBATED THE PATIENT AND PLACEMENT WAS FELT TO BE CORRECT. HOWEVER, THE PATIENT DEVELOPED SUBSEQUENT CARDIAC ARREST AND EXPIRED. THE TUBE WAS FOUND IN THE ESOPHAGUS ON AUTOPSY AND DISCARDED PRIOR TO COMPLETION OF THE REPORTDEVICE 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO- TRACHEAL TUBE CUFFED, MURPHY EYE ENDOTRACHEAL TUBE BSK MALLINCKRODT 86114 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death