BEUDAMED
    FDA Adverse Event Death Summary report: N

    LMA NORTH AMERICA

    MDR report key: 488854 · Received September 26, 2003

    Report

    Report Number
    488854
    Event Type
    Death
    Date Received
    September 26, 2003
    Date of Event
    August 14, 2003
    Report Date
    September 4, 2003
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM UF 1/22/04: PT DID NOT REGAIN CONSCIOUSNESS FOLLOWING RESUSCITATION. PT WAS DISCHARGED TO A HOSPICE CENTER 12 DAYS LATER AND EXPIRED TWO DAYS LATER. DRAGER NARKOMED 6000-BASIC ANESTHESIA MACHINE WAS EVALUATED BY THE COMPANY SERVICE REP ON 8/18/03 RESULTING IN FINDING NO ERROR FOUND IN LOGS CONSISTENT WITH A MACHINE PROBLEM. LARYNGEAL MASK AIRWAY (LMA) WAS EVALUATED (INFLATED AND CHECKED FOR LEAKS) BY MEDICAL STAFF ANESTHESIOLOGIST PEER. LMA WAS FOUND TO BE FUNCTIONAL AND USEABLE. RISK MGMT DEPT HAS POSSESSION OF THE LMA. INITIAL REPORT MADE TO MFR PRIOR TO COMPLETED INVESTIGATION. THE MFR HAS NOT EVALUATED THE LMA.

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR TRANSURETHRAL RESECTION OF PROSTATE GLAND. PT EXPERIENCED HYPOXIA THEN A CARDIAC ARREST SHORTLY AFTER THE SURGERY HAD BEGUN. THE ANESTHETIC REGIME WAS USE OF PROPOFOL, FENTANYL AND VERSED. A DRAGER 6000 ANESTHESIA MACHINE AND A LARYNGEAL MASK AIRWAY (CLASSIC) WERE IN USE AT THE TIME OF THE HYPOXIA AND CARDIAC ARREST. PT WAS INTUBATED AND RESUSCITATED. PT DID NOT REGAIN CONSCIOUSNESS FOLLOWING RESUSCITATION. PT WAS DISCHARGED TO A HOSPICE CENTER TWELVE DAYS LATER AND EXPIRED TWO DAYS AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LMA NORTH AMERICA LARYNGEAL MARK AIRWAY (CLASSIC) CAE LMA NORTH AMERICA, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death