BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASPIRATOR, SUCTION WITH 800CC

    MDR report key: 876453 · Received July 2, 2007

    Report

    Report Number
    1417592-2007-00035
    Event Type
    Death
    Date Received
    July 2, 2007
    Date of Event
    June 25, 2007
    Report Date
    June 29, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESIDENT WAS FOUND TO BE IN FULL CARDIOPULMONARY ARREST. THE CRASH CART WAS BROUGHT INTO THE ROOM. CPR WAS INITIATED. THE RESIDENT HAD A FROTHY SPUTUM AND THEY ATTEMPTED TO TURN ON THE SUCTION MACHINE, BUT IT WOULD NOT TURN ON. THEY HAD TWO OTHER NON-MEDLINE SUCTION MACHINES AND THEY WOULD NOT TURN ON EITHER. THE RESIDENT SUBSEQUENTLY DIED. WE ARE AWAITING THE RETURN OF THE SAMPLE(S) AND A FOLLOW UP REPORT WILL BE FILED WHEN CORRECTIVE ACTION IS DETERMINED.

    Description of Event or Problem · 1

    A RESIDENT IN THE FACILITY WAS FOUND TO BE IN FULL CARDIOPULMONARY ARREST. THE SUCTION MACHINE ON THE CRASH CART APPARENTLY WOULD NOT TURN ON. THE FACILITY TRIED TO USE TWO OTHER NON-MEDLINE SUCTION MACHINES, BUT THEY WOULD NOT TURN ON EITHER. THE EMT STAFF ARRIVED TO PROVIDE TREATMENT. THE RESIDENT DID NOT RESPOND AND HE SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRATOR, SUCTION WITH 800CC SUCTION MACHINE GCX MEDLINE INDUSTRIES, INC. HCS7000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death