BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-VAC SUCTION UNIT

    MDR report key: 1933787 · Received December 16, 2010

    Report

    Report Number
    9610483-2010-00004
    Event Type
    Death
    Date Received
    December 16, 2010
    Report Date
    November 19, 2010
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE MANUFACTURER, LMAS, THERE IS NO ALLEGATION FROM THE (B)(6) AMBULANCE SERVICE THAT THE V-VAC MALFUNCTIONED OR FAILED TO MEET SPECIFICATIONS. ACCORDING TO THE AMBULANCE PERSONNEL, THE DEVICE IS NOT SUITABLE FOR REMOVING LARGE QUANTITIES OF FLUIDS FROM THE AIRWAYS. REPORTEDLY, THE V-VAC MANUAL SUCTION UNIT WAS THE ONLY AVAILABLE MEDICAL SUCTION EQUIPMENT IN THE AMBULANCE. THE V-VAC MANUAL SUCTION UNIT HAS A CAPACITY OF 425 ML AND A FULL CARTRIDGE CAN BE REPLACED WITH A NEW EMPTY CARTRIDGE WITHIN SECONDS, WITHOUT THE USE OF TOOLS. PER THE DFU, IF A CARTRIDGE BECOMES FULL AND THE EXHAUST FILTER BECOMES CLOGGED (SUCTION STOPS) THE USER CAN FLIP OPEN THE EXHAUST FILTER CAP TO CLEAR THE CLOG AND ALLOW THE UNIT TO OPERATE AGAIN.

    Description of Event or Problem · 1

    LMAS HAS INFORMED LAERDAL MEDICAL CORPORATION OF A PT INCIDENT FROM (B)(6) INVOLVING A V-VAC MANUAL SUCTION UNIT. THE INITIAL REPORT WAS SENT BY (B)(6) DISTRIBUTOR TO LMAS ON NOV. 19, 2010. AN AMBULANCE CREW FROM (B)(6) AMBULANCE SERVICE OF (B)(6) ARRIVED ON SCENE OF A CARDIAC ARREST PT THAT WAS IN ASYSTOLE AND HAD THEIR RESPIRATORY TRACT FULL OF VOMIT. THE CREW HAD ONLY A V-VAC HANDLE AND ONE CARTRIDGE, AND IT WAS NOT POSSIBLE TO CLEAR ALL THE FLUIDS FROM THE AIRWAY. THE PT DID NOT SURVIVE AND THE USER REPORTS IT IS CONCEIVABLE THAT THE MINIMAL DELIVERED SUPPLY OF OXYGEN, DUE TO THE STILL BLOCKED AIRWAY, CONTRIBUTED TO THE DEATH. THEY REPORT THE V-VAC DOES NOT WORK IN PRACTICE ON PTS WITH LARGER AMOUNTS OF FLUID IN THE UPPER AIRWAYS. NO EVENT DATE OR PT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-VAC SUCTION UNIT MANUAL ASPIRATOR BTA LAERDAL MEDICAL A.S. V-VAC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death