BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT SILICONE RESUSCITATOR

    MDR report key: 12943 · Received March 3, 1994

    Report

    Report Number
    12943
    Event Type
    Death
    Date Received
    March 3, 1994
    Date of Event
    February 14, 1994
    Report Date
    March 3, 1994
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO HOSP ER VIA EMS FOLLOWING SEVERE RESPIRATORY DISTRESS FOR 2 HRS. THE PT WAS TRIAGED AND TREATED WITHIN ONE MIN OF ARRIVAL. RESPIRATORY AND ANESTHESIA WERE CALLED TO INTUBATE AND VENTILATE PT DURING CODE. AMBU BAG USED WITH MASK FUNCTIONED APPROPRIATELY. AFTER INTUBATION SAME AMBU BAG USED ON END OF ENDO TRACH TUBE MET WITH OCCASIONAL RESISTENCE DURING VENTILATION. PT WAS REINTUBATED DURING WHICH TIME THE RESUSITATOR WAS CHECKED. RESPIRATORY DISCOVERED 2 FISH MOUTH VALVES INSTEAD OF ONE HAD BEEN ASSEMBLED INTO THE UNIT. ONE VALVE WAS REMOVED AND EQUIPMENT REASSEMBLED. NO FURTHER RESISTENCE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT SILICONE RESUSCITATOR ADULT SILICONE RESUSCITATOR BTM LAERDAL MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death